PleurX 50-7500BRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10885403090714), received between Nov 16, 2017 and Mar 13, 2026 — classified as 3 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT THE PLEURX DRAINAGE KIT PLUNGER WAS DEFECTIVE. NO PATIENT HARM WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE DRAIN VALVE BROKE. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL FOLLOW UP RECEIVED BY THE CUSTOMER STATED THE PIECE CONNECTED TO THE CATHETER THAT IS INSERTED IN THE PATIENT'S LUNG IS THE COMPONENT THAT BROKE AND THAT THE BOTTLE PLUNGER WAS NOT BROKEN. THE CATHETER/TUBE WAS NOT REPLACED BUT WAS CUT, MADE SHORTER AND ADDED A REPLACEMENT VALVE. THE PATIENT WAS SUCCESSFULLY TREATED WITHOUT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599380 ↗
• MalfunctionJul 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT HALFWAY USING TWO PLEURX BOTTLE PRODUCTS, THE TUBING OF THE PLUNGERS DISCONNECTED CAUSING A BLOOD LEAKAGE FROM THE DRAINAGE LINE AND VALVE OF THE CATHETERS AND SPILLED EVERYWHERE INCLUDING THE HEALTH CARE PROVIDER'S (HCP) HANDS, HOWEVER, THE HCP WAS WEARING GLOVES. IT WAS FURTHER REPORTED THAT THE TREATMENT WAS CEASED AND ATTEMPTED AGAIN THE SAME AFTERNOON WITH A THIRD BOTTLE OF A DIFFERENT BATCH TO DRAIN THE PATIENT. THERE WAS NO HARM OR IMPACT TO THE PATIENT OR HCP, AND ADDITIONAL MEDICAL INTERVENTION WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22614711 ↗
• MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT HALFWAY USING TWO PLEURX BOTTLE PRODUCTS, THE TUBING OF THE PLUNGERS DISCONNECTED CAUSING A BLOOD LEAKAGE FROM THE DRAINAGE LINE AND VALVE OF THE CATHETERS AND SPILLED EVERYWHERE INCLUDING THE HEALTH CARE PROVIDER'S (HCP) HANDS, HOWEVER, THE HCP WAS WEARING GLOVES. IT WAS FURTHER REPORTED THAT THE TREATMENT WAS CEASED AND ATTEMPTED AGAIN THE SAME AFTERNOON WITH A THIRD BOTTLE OF A DIFFERENT BATCH TO DRAIN THE PATIENT. THERE WAS NO HARM OR IMPACT TO THE PATIENT OR HCP, AND ADDITIONAL MEDICAL INTERVENTION WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22614696 ↗
• InjuryMay 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION TO ALLEGED PLASTERS AFTER THE PLEURX DRAINAGE PROCEDURE. IT WAS FURTHER REPORTED THAT THE DEFECT LOCATION WAS THE FOIL BOND. PATIENT ADDITIONAL TREATMENT AND PATIENT STATUS IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22069818 ↗
• MalfunctionMay 7, 2025Unsealed Device Packaging; Unsealed Device Packaging

  INJURY (PATIENT / OTHER): NO. DEVICE POSSIBLY INVOLVED IN INJURY: NO. DEVICE AVAILABLE FOR EXAMINATION: NO. DETECTION SITE: 2 - ON APPLICATION. ORIGIN: PATIENT. COMPLAINT: 0.1VE: FOIL / PACKAGING NOT SEALED AT THE BOTTOM. PRODUCT WAS DISCARDED BECAUSE IT WAS NOT STERILE PACKED. INFORMATION ON THE DEFECT: DEFECT LOCATION: STERILE PACKAGING TYPE OF ERROR: NOT CORRECT / UNIFORM / CONSISTENT (FAULTY) DEFECT LOCATION: VACUUM FLASK TYPE OF DEFECT: DAMAGED (BROKEN, BRITTLE, DEFORMED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981319 ↗
• MalfunctionDec 24, 2024Crack; Crack

  MATERIAL NO: 50-7500B BATCH NO: 0001567492. IT WAS REPORTED THAT THE ACCESS TIP WAS CRACKED. THERE WAS NO PATIENT HARM. VERBATIM: IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: ¿DEFECTIVE CAP¿. RCC RECEIVED A COMPLAINT VIA EMAIL. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? 2 KITS HAD ACCESS TIP WAS CRACKED /1 KIT HAD A DRIED ALCOHOL PAD ACCORDING TO CUSTOMER ALL FROM SAME LOT. WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE CAP? TO THE ACCESS TIP LEAKAGE DID OCCUR ON ONE OF THE TWO CRACKED ACCESS TIPS, THE OTHER WAS CAUGHT BEFORE. WHAT WAS THE IMPACT TO THE PATIENT? NO . DID THE ISSUE HAPPEN DURING PATIENT USE? YES DURING DRAINING IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? NO IF YES, PLEASE PROVIDE MAILING ADDRESS AND EMAIL ADDRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011566 ↗
• MalfunctionDec 24, 2024Product Quality Problem; Product Quality Problem

  MATERIAL NO: 50-7500B BATCH NO: 0001567492. IT WAS REPORTED THAT THE KIT HAD DRIED ALCOHOL PAD. THERE WAS NO PATIENT HARM. VERBATIM: IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM EVENT DESCRIPTION STATES: ¿DEFECTIVE CAP¿. RCC RECEIVED A COMPLAINT VIA EMAIL. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? 2 KITS HAD ACCESS TIP WAS CRACKED /1 KIT HAD A DRIED ALCOHOL PAD ACCORDING TO CUSTOMER ALL FROM SAME LOT. WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE CAP? TO THE ACCESS TIP LEAKAGE DID OCCUR ON ONE OF THE TWO CRACKED ACCESS TIPS, THE OTHER WAS CAUGHT BEFORE. WHAT WAS THE IMPACT TO THE PATIENT? NO. DID THE ISSUE HAPPEN DURING PATIENT USE? YES DURING DRAINING IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? NO IF YES, PLEASE PROVIDE MAILING ADDRESS AND EMAIL ADDRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011562 ↗
• MalfunctionNov 4, 2024Product Quality Problem; Product Quality Problem

  ALCOHOL PAD DRY INJURY (PATIENT/OTHER): NO PRODUCT POSSIBLE INVOLVED IN INJURY: NO PRODUCT AVAILABLE FOR INQUIRY: NO FIXED LOCATION: 2 - WHEN USED ORIGIN: PATIENT COMPLAINT: ALCOHOL PAD DRY INFORMATION ON THE ERROR PATTERN: FAULT LOCATION: ALCOHOL SWAB ERROR TYPE: DRY COULD YOU PLEASE PROVIDE TOTAL NUMBER OF OCCURRENCES ASSOCIATED WITH REPORTED LOT NUMBERS 0001554159, 0001551811.- NO OTHER COMPLAINTS REPORTED IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE?- NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604491 ↗
• MalfunctionJul 10, 2024Sharp Edges; Sharp Edges

  RCC RECEIVED A COMPLAINT VIA EMAIL. 'NO SUCTION WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE BOTTLE? YES, THEY ARE REPORTING THAT THERE WAS AN EXTRA PIECE OF PLASTIC ON THE END OF THE ACCESS TIP OF THE DRAINAGE LINE THAT CONNECTS TO THE CATHETER COMING OUT OF THE PT WALL. CUSTOMER SAID THAT THREE BOTTLES HAD THE ISSUE AND WAS ADVISED TO OPEN A NEW BOX TO OBTAIN WORKING BOTTLE WAS THERE VACUUM ISSUE? NO WAS THERE ANY INDICATION OR SOUND OF VACUUM ESCAPING? NA WHERE ARE THE BOTTLES STORED UNTIL USE? WAS THE CLAMP PROPERLY CLOSED UNTIL AFTER ACTIVATING THE SUCTION? YES WERE THEY ABLE TO USE ANOTHER BOTTLE SUCCESSFULLY? YES WHAT WAS THE IMPACT TO THE PATIENT? NO DID THE ISSUE HAPPEN DURING PATIENT USE? NO BEFORE DRAINING ACTUALLY HAPPENED IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? NO IF YES, PLEASE PROVIDE MAILING ADDRESS AND EMAIL ADDRESS. CUSTOMER SAID IT WAS NOT THE VALVE REPLACEMENT CAP IT WAS THE ACCESS TIP OF THE DRAINAGE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710436 ↗
• MalfunctionMay 17, 2024Unsealed Device Packaging; Unsealed Device Packaging

  PLEURX DRAINAGE KIT WAS NOT PACKED PROPERLY. THE PACKET WAS OPENED WHEN THE ITEM WAS TAKEN OUT FROM THE BOX. WHEN DID THE INCIDENT OCCUR - BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345191 ↗
• MalfunctionMay 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  LEAKY CONNECTION BETWEEN PLEURX CATHETER VALVE AND BOTTLE ACCESS TIP. WHEN IT STARTED TO DRAIN, THE CONNECTION BETWEEN THE PLEURX CATHETER VALVE AND BOTTLE ACCESS TIP WAS LEAKING. A NEW BOTTLE WAS USED AND THE ISSUE WAS RESOLVED. 07-MAY-2024 - RECEIVED AN EMAIL RESPONSE FROM COMPLAINANT FOR INFORMATION. ANSWERS ADDED IN FOLLOW UP TAB. (B)(6) HAPPENED TO THE SAME PATIENT ON 1 OCCASION. WHERE DID LEAKAGE OCCURRED? FROM THE ACCESS TIP AND THE CATHETER VALVE. IS THIS AT THE ACCESS TIP AND THE CATHETERS VALVE? IF IT AT THE ACCESS TIP DID THE ACCESS TIP FULLY CLICKED IN TO THE VALVE? YES, ACCORDING TO THE CUSTOMER. DID THE LEAKAGE OCCURRED TO THE DRAINAGE LINE TO THE BOTTLE? DO YOU MEAN TO SAY THAT THE LEAKAGE WAS FROM THE LINE? WAS THERE DAMAGE NOTED ON THE ACCESS TIP OR PATIENT'S VALVE. NO. NOT AT THE ENTRY POINT. WHERE IS THE CATHETER LOCATED? CHEST. WHAT WAS THE IMPACT TO THE PATIENT? PATIENT WAS DISTRESSED. HOW WAS THE ISSUE RESOLVED? A NEW BOTTLE WAS USED. THE PLEURX DRAIN WAS ACCESSED WITH PLEURX BOTTLE, WHICH THEN PROCEEDED TO LEAK. I DISCONNECTED THE DRAIN AND ATTACHED ANOTHER PLEURX BOTTLE, AND DRAINED WITHOUT INCIDENT 400MLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287612 ↗
• MalfunctionMay 9, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS LEAKAGE AT THE CATHETER END AND THE DRAINAGE BOTTLE LINE. VERBATIM: - WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE BOTTLE? NO - WAS THERE ANY INDICATION OR SOUND OF VACUUM ESCAPING? NO - WHERE ARE THE BOTTLES STORED UNTIL USE? IN BOX THEY - WAS THE CLAMP PROPERLY CLOSED UNTIL AFTER ACTIVATING THE SUCTION? YES - WERE THEY ABLE TO USE ANOTHER BOTTLE SUCCESSFULLY? YES - WHAT WAS THE IMPACT TO THE PATIENT? NO - DID THE ISSUE HAPPEN DURING PATIENT USE? YES IF YES, WAS THERE ANY INJURY? NO IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? NO - IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? NO IF YES, PLEASE PROVIDE MAILING ADDRESS AND EMAIL ADDRESS. PLEASE ADD LEAKAGE AS THE CUSTOMER SAID THERE WAS LEAKAGE AT THE CATHETER END AND THE DRAINAGE BOTTLE LINE. THEY STOPPED THE DRAINING AND OPENED A NEW BOTTLE WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281574 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: ACCESS TIP END OF THE BOTTLE LINE CRACKED AND WAS STUCK TO THE CATHETER END COMING OUT OF PT WALL. GRANDAUGHTER WAS ABLE TO REMOVE IT WITH TWEEZERS SUCCESSFULLY AND OPEN A NEW BOTTLE TO DRAIN. ARE THEY ABLE TO DRAIN SUCCESSFULLY WITH THE NEW BOTTLE? YES. WAS THE CLAMP PROPERLY CLOSED UNTIL AFTER THE PLUNGER WAS PRESSED? NA. WHERE IS THE CATHETER LOCATED? CHEST . IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? NO. WHAT WAS THE IMPACT TO THE PATIENT? NO. WAS THERE ANY SOUNDS OR HISSING? NA. HOW WHERE THE BOTTLES STORED BEFORE USE? IN BOX THEY COME IN. WAS THE ACCESS TIP THAT WAS CRACKED ISSUE IDENTIFIED BEFORE USE OR DID THEY OBSERVE THE CRACKED ACCESS TIP AFTER REMOVAL WITH THE TWEEZERS? - THE CRACK WAS OBSERVED AFTER IT WAS REMOVED WITH THE TWEEZERS. TOTAL OCCURRENCES ARE 2- COULD YOU PLEASE PROVIDE FURTHER INFORMATION ABOUT 2 OCCURRENCES? WERE THERE TWO SEPARATE EVENTS INVOLVED? SPECIFY THE PRODUCT FAILURE. - I BELIEVE THERE WAS MISCOMMUNICATION, CUSTOMER STATED IT HAPPENED ONCE, BUT BECAUSE THIS ISSUE OCCURRED THERE WAS NO SUCTION. REPORTED ISSUE "ACCESS TIP END OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951323 ↗
• MalfunctionDec 5, 2023Leak/Splash; Leak/Splash

  VIOLATION (PATIENT / OTHER): NO. PRODUCT POSSIBLY INVOLVED IN INJURY: NO. PRODUCT AVAILABLE FOR EXAMINATION: NO. DETECTION SITE: 2 - ON APPLICATION. ORIGIN: PATIENT. COMPLAINT: PATIENT HAS CONNECTED A RESERVOIR WITH A VALVE, FLUID LEAKED AT THE CONNECTION POINT. THEY CONNECTED ANOTHER RESERVOIR AND EVERYTHING WAS TIGHT. PRODUCT INFORMATION: ITEM NO.: 50-7500B/V001 - PLEURX¿ DRAINAGE SET, 500 ML RESERVOIR INCL. ACCESSORIES PU (PACKAGING UNIT) (B)(4) PIECES. ADDITIONALLY AFFECTED ITEM NO.: 50-7500B/V001 - PLEURX¿ DRAINAGE SET, 500 ML RESERVOIR INCL. ACCESSORIES PU (PACKAGING UNIT) (B)(4) PIECES. ADDITIONALLY AFFECTED LOT NO.: 0001496988. ADDITIONAL INFORMATION: DESCRIPTION OF ISSUE (WHAT / WHY): PATIENT HAS CONNECTED A RESERVOIR WITH A VALVE, FLUID LEAKED AT THE CONNECTION POINT. THEY CONNECTED ANOTHER RESERVOIR AND EVERYTHING WAS TIGHT. HOW OFTEN OCCURED DEFECT: ONCE. MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO. NEEDLE/PROBE STICK: NO. OTHER ACTIONS TAKEN: NO. SAFETY ISSUE: NO. ISSUE RESOLVED: YES. HOW ISSUE RESOLVED / ADDITIONAL INFORMATION: REPLACEMENT. PHOTO / SAMPLE AVAILABLE: NO. SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED: NO. SAFETY CLAMP OPEN, WHEN VALVE BROKE/DAMAGED/D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267154 ↗
• MalfunctionNov 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT REGISTERED NURSE WAS EMPTYING PLEURX DRAIN. CONNECTOR "CLICKED" INTO POSITION AS EXPECTED, HOWEVER UPON RELEASING THE ROLLER CLAMP AND BEGINNING TO DRAIN, THE CONNECTOR PIECE OF THE PLEURX DRAIN BEGAN TO LEAK AND WAS "SUCKING" AIR IN ADDITION TO PULLING PLEURAL FLUID. ESSENTIALLY THERE WAS AN AIR LEAK AT THE CONNECTION SITE. RN STOPPED DRAINING AT THIS TIME. PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, HOWEVER OBTAINED CHEST XRAY AFTERWARDS TO MAKE SURE NO HARM WAS DONE. VERBATIM RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REGISTERED NURSE WAS EMPTYING PLEURX DRAIN. CONNECTOR "CLICKED" INTO POSITION AS EXPECTED, HOWEVER UPON RELEASING THE ROLLER CLAMP AND BEGINNING TO DRAIN, THE CONNECTOR PIECE OF THE PLEURX DRAIN BEGAN TO LEAK AND WAS "SUCKING" AIR IN ADDITION TO PULLING PLEURAL FLUID. ESSENTIALLY THERE WAS AN AIR LEAK AT THE CONNECTION SITE. RN STOPPED DRAINING AT THIS TIME. PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, HOWEVER OBTAINED CHEST XRAY AFTERWARDS TO MAKE SURE NO HARM WAS DONE. PER EMAIL RECEIVED ON 11/09/2023: 1. THE LEAKAGE OCCURRED BETWEEN THE ACCESS TIP AND THE CATHETER VALVE, HARD TO TELL WHICH IS ORIGINATED FROM. 2. NO DAMAGE NOTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187844 ↗
• InjuryOct 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PLEASE SEE THIS EXTENSIVE RASH . PLEASE SEE ATTACHED EMAIL REGARDING FURTHER ISSUES WITH THE TEGADERM IN THE PLEURX DRESSING PACK. I HAVE ATTACHED THE ORIGINAL PRODUCT COMPLAINT FORM AND PLEASE SEE EMAIL CHAIN BELOW REGARDING THIS SAME ISSUE. I HAVE NO OTHER INFORMATION REGARDING THIS MATTER AND HAVE ALSO NOT HEARD OF THIS HAPPENING ELSEWHERE. CUSTOMER FEELS THAT SOMETHING HAS CHANGED IN THE TEGADERM THAT COVERS THE DRESSING FOR PATIENTS WITH A PLERUX. SHE HAS EXPERIENCED PATIENTS HAVING SORENESS / REDNESS AND A SLIGHT RASH AFTER IT HAS BEEN USED. 26 OCT 2023 - RESPONSE: AS FAR AS I CAN REMEMBER, I HAVE SENT 2 PICTURES, BUT BOTH BELONG TO THE SAME PATIENT AND THE RASH IS GETTING WORSE AS YOU CAN SEE. THE LOT NUMBERS ARE NOT AVAILABLE TO ME AS THE DRESSINGS ARE DONE BY THE DISTRICT NURSES. THE MEDICAL INTERVENTION NEEDED INCLUDE STEROID TREATMENT, ANTIBIOTICS AND ONGOING REVIEW. THE ISSUE HAS NOT FULLY RESOLVED AS THE GENTLEMAN STILL ONGOING CARE, BUT HOPEFULLY IT MIGHT IMPROVE AS THE IPC HAS NOW BEEN REMOVED.

  Patient problems: Rash

  MAUDE report 18030057 ↗
• MalfunctionOct 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM EVENT DESCRIPTION STATES: THE TIP OF IT WAS BROKEN. - COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? THE TUBE THAT COMES OFF THE BOTTLE WAS DETACHED. - WAS THE ACCESS TIP BROKEN OR DAMAGED? NO. - WAS IT THE ACCESS TIP THAT WAS CRACKED? NO. - WAS THE ACCESS TIP OF DRAINAGE LINE BROKEN OFF IN THE CATHETER. NO. - WHERE IS THE CATHETER LOCATED? ABDOMEN OR CHEST-ABDOMEN. - IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? NO. - WHAT WAS THE IMPACT TO THE PATIENT? NO. - WAS THE ISSUE IDENTIFIED BEFORE USE AND THE PRODUCT DISCARDED OR DID, THEY IDENTIFY DURING USE? DURING USE AND THE PRODUCT WAS DISCARDED. - WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? NO. - WHAT WAS DONE TO RESOLVE THE ISSUE. GOT A NEW BOTTLE. PER FOLLOW-UP INFORMATION RECEIVED ON 10/06/2023. PLEASE REACH OUT AND REQUEST TO VERIFY THE FOLLOWING: - WAS THE DRAINAGE LINE DISCONNECTED FROM THE BOTTLE AT ANY POINT DURING THE DRAIN OR WAS IT NOTICED PRIOR TO DRAINAGE? ONCE SHE OPEN THE HOSE IS STARTED TO LEAK FOR THE BOTTLE. - IF IT'S BEFORE USE AND DID THEY ATTEMPT TO REC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17907935 ↗
• MalfunctionJul 13, 2023Product Quality Problem; Product Quality Problem

  DESCRIPTION OF THE PROBLEM (WHAT / WHY) - ALCOHOL WIPE DRY. HOW OFTEN DID THE DEFECT OCCUR - 10 MEDICAL INTERVENTION (OTHER THAN FIRST AID) - NOT REQUIRED. NEEDLE STICK/PROBE STICK - NOT REQUIRED. OTHER MEASURES TAKEN - YES SAFETY PROBLEM - NO PROBLEM SOLVED - JA HOW WAS THE PROBLEM RESOLVED / ADDITIONAL INFORMATION - REPLACE. PHOTO / SAMPLE AVAILABLE - NO SAFETY VALVE BROKEN / DAMAGED / DEFECTIVE - NO INFORMATION / NOT APPLICABLE. SAFETY CLAMP OPEN IF VALVE BROKEN. / DAMAGED. / D.. - NO INFORMATION / NOT APPLICABLE. SAFETY VALVE LUG BROKEN / DAMAGED - NO SPECIFICATION / NOT APPLICABLE. LOCKING TAB BROKEN / DAMAGED - NO INDICATION / NOT APPLICABLE. LEAKAGE - NO INDICATION / NOT APPLICABLE. SUCCESSFUL DRAINAGE - YES CONTACT WITH BLOOD / BODY FLUIDS - NO INDICATION / NOT APPLICABLE. CHANGE IN COURSE OF TREATMENT DUE TO EVENT - NO INDICATION / NOT APPLICABLE. TIME SPENT IN CATHETER - 2023-01-31 WHERE IS THE CATHETER LOCATED: IN THE ABDOMEN OR CHEST? - CHEST CONNECTED DEVICE (PLEURX/PERITX/BRAND) - 50-7500B PROCEDURE PERFORMED BY - PATIENT PERFORMED IN - HOME ADDITIONAL INFORMATION - NONE / NOT RELEVANT 0,8 VE LOT 0001460729. 0.2 VE LOT 0001464175.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321377 ↗
• MalfunctionApr 19, 2023Break; Break

  DESCRIPTION OF THE PROBLEM (WHAT / WHY) - ACCESS PIN LEAKING HOW MANY TIMES DID THE DEFECT OCCUR - ONCE MEDICAL INTERVENTION (OTHER THAN FIRST AID) - NO NEEDLE STICK/PROBE STICK - NOT REQUIRED. OTHER MEASURES TAKEN - NO INDICATION / NOT APPLICABLE. SAFETY PROBLEM - NO PROBLEM SOLVED - YES HOW WAS THE PROBLEM SOLVED / ADDITIONAL INFORMATION - ACCESS PIN REMOVED, REPLACEMENT USED. PHOTO / SAMPLE AVAILABLE - YES SAFETY VALVE BROKEN / DAMAGED / DEFECTIVE - NO INDICATION / NOT APPLICABLE. SAFETY CLAMP OPEN IF VALVE BROKEN. / DAMAGED. / D.. - NO INDICATION / NOT APPLICABLE. SAFETY VALVE LUG BROKEN / DAMAGED - NO INDICATION / NOT APPLICABLE. LOCKING TAB BROKEN / DAMAGED - NO INDICATION / NOT APPLICABLE. LEAKAGE - NO INDICATION / NOT APPLICABLE. SUCCESSFUL DRAINAGE - YES IMPACT ON PATIENT - HAD TO USE ANOTHER BOTTLE. CONTACT WITH BLOOD / BODY FLUIDS - NO INDICATION / NOT APPLICABLE CHANGE IN COURSE OF TREATMENT DUE TO EVENT - NO INDICATION OF THIS / NOT APPLICABLE. TIME SPENT IN CATHETER - (B)(6) 2023 WHERE IS THE CATHETER LOCATED: IN THE ABDOMEN OR CHEST? - CHEST CONNECTED DEVICE (PLEURX/PERITX/BRAND) - 50-7500B PROCEDURE PERFORMED BY - EMPLOYEE EWIMED PERFORMED AT - HOME ADDITIONAL INFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769487 ↗
• MalfunctionJan 13, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: BOTTLES WERE OPEN IN BOX. ON (B)(6) 2023: CUSTOMER STATE THAT INITIALLY CONFIRMED THAT CALL WAS ABOUT INSURANCE COVERAGE. CUSTOMER SAID THAT THE BOTTLES WERE NOT SEALED IN PACKAGING WHEN SHE WENT TO USE THEM. HOWEVER, WAS ABLE TO DRAIN SUCCESSFULLY WITH ANOTHER BOTTLE AND EP DID REPLACE BOTTLES, DIDN'T REMEMBER THE EXACT NUMBER THAT WERE NOT PACKAGED CORRECTLY. HOW MANY BOTTLES WERE NON-USABLE: HAPPENED TWICE FOR TWO DIFFERENT SHIPMENTS. NO DAMAGE TO SHIPPING BOX. NO DAMAGE TO INSIDE BOX. DISCARDED BOTTLES. DID NOT RECORD THE LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158945 ↗
• InjuryDec 13, 2022Suction Failure; Suction Failure

  IT WAS REPORTED BY THE CUSTOMER THAT THEY EXPERIENCE NO SUCTION ISSUE WITH 12 BOTTLES. VERBATIM: PI - PPA - CALLED CUSTOMER TO FOLLOW UP ON PRS 6641712 AND 6654560, WHILE SPEAKING CUSTOMER WIFE MENTIONED THAT THEY ENDED UP USING 12 MORE BOTTLES ALL WITH NO SUCTION ISSUES. WIFE ADVISED THAT THEY CALLED EP TODAY TO REPORT THIS AND ARE RECEIVING 14 MORE REPLACEMENTS FROM EP, TO COVER A TOTAL OF 20 BOTTLES WITH NO SUCTION ISSUES, PREVIOUSLY RECEIVED 6 BOTTLES. THEY WOULD ONLY DRAIN TO GRAVITY. WIFE STATES THAT THEY WERE ABLE TO THEN USE A DIFFERENT BOTTLE EACH TIME AND DRAIN SUCCESSFULLY. WHEN THE BOTTLES WERE NOT WORKING, CUSTOMER WOULD ONLY GET ABOUT 5-10ML TO COME OUT AS OPPOSED TO WHEN THE BOTTLES DID WORK, AND IT WAS DRAINING 200 TO 250ML. WIFE IS RECEIVING REPLACEMENT FROM EP, THEY ARE ORDERED AND WILL BE SENT ASAP. ISSUE HAS OCCURRED WITH 20 BOTTLES TOTAL. 8 BOTTLES ALREADY REPORTED TO BD ON PR 6640516, PER BY THE TIME WIFE TALKED TO US, ISSUE HAD OCCURRED WITH THE ORIGINAL 6 REPORTED TO EP AND THEN TWO ADDITIONAL. WIFE ADVISED THAT UPON TALKING WITH NURSE, THEY FEEL THE CUSTOMER NEEDS 1000ML BOTTLES, CUSTOMER IS IN PROCESS OF GETTING THE BOTTLES CHANGED THROUGH EP. WIFE STATES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970869 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE TIP OF THE DRAINAGE DEVICE BROKE OFF UPON INSERTION. VERBATIM: PATIENT HAD A PLEUR-X CATHETER PLACED YESTERDAY FOR MALIGNANT EFFUSION. I ASSESSED THE CATHETER THIS MORNING AND FOUND THE INSERTION SITE PATENT. I ATTEMPTED TO ACCESS THE PLEUR-X CATHETER WITH A STANDARD PLEUR-X ACCESS AND DRAINAGE KIT AND THE TIP OF THE DRAINAGE DEVICE BROKE OFF IMMEDIATELY UPON INSERTION INTO THE ACCESS VALVE OF THE PLEUR-X CATHETER. THE ACCESS VALVE OF THE PLEUR-X CATHETER ALSO BECAME CRACKED WHEN THE TIP OF THE DRAINAGE DEVICE SNAPPED OFF. PLEURAL FLUID AT THIS POINT WAS BEGINNING TO FLOW FREELY FROM THE PLEUR-X CATHETER, SO THE BLUE EMERGENCY CLAMP WAS PLACED ONTO THE TUBING OF THE PLEUR-X AND A TEGADERM WAS WRAPPED AROUND THE ACCESS VALVE (THE CAP CANNOT BE PLACED ON THE VALVE CORRECTLY DUE TO THE CRACK IN THE PLASTIC OF THE VALVE). DR. (B)(6) (THE INTERVENTIONAL RADIOLOGIST) WHO PLACED THE CATHETER, DR.(B)(6) (MY ATTENDING PHYSICIAN), THE PATIENT AND HIS PARTNER ABIGAIL WERE ALL MADE AWARE OF THE INCIDENT AS SOON AS IT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327036 ↗
• MalfunctionApr 21, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ACCESS TIP HAS A HOLE. VERBATIM: JUST GOT ANOTHER DEFECTIVE PLUREX KIT. WHITE TIP HAS A HOLE IN IT. THIS MAKES NUMBER 4. I THINK WE WOULD LIKE YOU TO SEND US 4 REPLACEMENT KITS. MY MOM'S NAME IS (B)(6) DOB (B)(6) 1935. HER ADDRESS IS /OMIT/.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176515 ↗
• MalfunctionFeb 15, 2022Material Twisted/Bent; Material Twisted/Bent

  THE BOTTLES DON'T WORK. THE INSERTION PIN IS SEVERELY CURVED. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? "THE INSERTION PIN IS SEVERELY CURVED." YES, THE ACCESS TIP. WAS THE ACCESS TIP BENT? YES THE ACCESS TIP. WAS THE T PLUNGER BROKEN OR CURVED? NO. WAS THERE VACUUM ISSUE? NO. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? THERE ARE NO PHOTOS OR SAMPLES AVAILABLE. WHAT WAS THE IMPACT TO THE PATIENT? NO IMPACT. WHERE IS THE CATHETER LOCATED? ABDOMEN OR CHEST? CHEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535132 ↗
• MalfunctionFeb 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  VALVE DRIPS WHEN ACCESS TIP IS CONNECTED. IF NONE IS CONNECTED, THE VALVE IS TIGHT. THE ACCESS TIP MIGHT BE THE PROBLEM HERE. WHERE DID LEAKAGE OCCURRED? > VALVE DRIPS WHEN ACCESS TIP IS CONNECTED. IF NONE IS CONNECTED, THE VALVE IS TIGHT. THE ACCESS TIP MIGHT BE THE PROBLEM HERE. IS THIS AT THE ACCESS TIP AND THE CATHETERS VALVE? IF IT AT THE ACCESS TIP DID THE ACCESS TIP FULLY CLICKED IN TO THE VALVE? > ACCESS TIP. YES FULLY CLICKED. WAS THERE DAMAGE NOTED ON THE ACCESS TIP OR PATIENT'S VALVE. > UNKNOWN. WHERE IS THE CATHETER LOCATED? > CHEST. IS THERE A SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? > I HAVE TO CHECK THIS. WHAT WAS THE IMPACT TO THE PATIENT? > NO IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13443241 ↗