PleurX 50-7510Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 10885403090707), received between Mar 1, 2016 and Jul 20, 2026 — classified as 2 deaths, 7 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25881806 ↗
• MalfunctionJul 20, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25881651 ↗
• MalfunctionMar 20, 2026Unsealed Device Packaging

  IT WAS REPORTED BY CUSTOMER THAT PLEURX DRAINAGE KIT MANUFACTURED BOX WAS OPENED NOT SEALED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE OUTER CARTON OR SHIPPING BOX WAS CUT OPENED. SEEMED LIKE AN ISSUE WITH THE CARRIER. THE INTERNAL BAG OR PACKAGE CONTAINING THE BOTTLE WAS ALSO CUT OPEN, AS IT HAD BEEN SLICED THROUGH. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24655928 ↗
• MalfunctionFeb 24, 2026Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT ON (B)(6) 2026, THE DURING ROUTINE PLEURX DRAIN CARE, STAFF NOTICED A WET SPOT ON THE STERILE DRAPE. UPON INSPECTION, THEY FOUND THAT THE TUBING ATTACHED TO THE PLEURX BOTTLE WAS LEAKING FLUID ONTO THE STERILE FIELD. THE DRAINAGE PROCEDURE WAS STOPPED, THE LEAKING BOTTLE WAS DISCONNECTED, AND A NEW BOTTLE AVAILABLE IN THE HOME WAS ATTACHED. THE DEVICE INVOLVED WAS NOT IMPLANTED AND NOT RETAINED. NO PATIENT INJURY WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE LEAKAGE OCCURRED BETWEEN THE DISTAL END OF THE ACCESS TIP AND THE ATTACHED DRAINAGE LINE. THERE WAS NO DAMAGE NOTED TO THE ACCESS TIP OR THE PATIENT'S VALVE. THE PATIENT'S CATHETER IS AN ABDOMINAL PLEURX ON THEIR RIGHT SIDE. DUE TO THE LEAKAGE, BODILY FLUID LEAKED ON TO PATIENT'S LAP, SATURATING A SMALL PORTION OF THEIR PANTS AND ON TO THEIR CHAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434796 ↗
• MalfunctionJan 20, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PLEURX DRAINAGE KIT DRESSING WAS NOT INTACT/STERILE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125930 ↗
• MalfunctionOct 15, 2025Device Contaminated at the User Facility; Device Contaminated at the User Facility

  IT WAS REPORTED THAT DURING AN ATTEMPT TO USE THE PLEURX DRAINAGE KIT BY END USER/LAY PERSON AT HOME, THE BOTTLE WAS FOUND CONTAMINATED AS IT APPEARED TO ALREADY HAVE BEEN USED. THE ISSUE WAS RESOLVED BY REPLACING THE BOTTLE WITH A NEW ONE. THE PATIENT WAS SUCCESSFULLY DRAINED, AND NO PATIENT INJURY WAS REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT EXPOSURE TO BLOOD/BODILY FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280741 ↗
• MalfunctionSep 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE PLEURX DRAINAGE KIT WAS FOUND TO BE CONTAMINATED AND APPEARED TO HAVE ALREADY BEEN USED. ANOTHER DEVICE WAS USED TO DRAIN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083623 ↗
• MalfunctionSep 4, 2025Contamination; Contamination

  IT WAS REPORTED THAT ON (B)(6) 2025 BEFORE USE OF THE PLEURX DRAINAGE KIT, A YELLOW SUBSTANCE WAS OBSERVED ON THE OUTSIDE AND INSIDE OF THE PACKAGING. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963495 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEAKAGE OCCURRED AT THE INSERTION SITE WHERE PT WALL AND CATHETER ARE LOCATED AT THE RIGHT SIDE 6 INCHES ABOVE THE NAVEL. IT WAS FURTHER REPORTED THAT THE DOCTOR CONFIRMED THERE WAS NOTHING WRONG WITH THE CATHETER. THE PATIENT WAS PRODUCING MORE FLUID THAT REQUIRED EXTRA DRAINING. PATIENT CONFIRMED THAT THE ISSUE HAS BEEN RESOLVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22449483 ↗
• MalfunctionJun 25, 2025Leak/Splash; Leak/Splash

  A LEAKY HOSE WAS REPORTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333147 ↗
• MalfunctionMay 21, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY CUSTOMER THAT THE TIP DOES NOT FIT ONTO PT DRAIN, HAS A SPIKE SECTIONING OUT THE TUBING THAT IS USED TO CONNECT TO THE PT SIDE OF THE TUBING, AND THE TUBING NOW HAS A HOLE IN IT.

  Patient problems: Insufficient Information

  MAUDE report 22066866 ↗
• MalfunctionJan 29, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: DRY ALCHOL¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269961 ↗
• MalfunctionJan 17, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED BY CUSTOMER THAT TWO BOTTLES DID NOT HAVE PACKAGING COMPROMISING THE BOTTLES. IT WAS FURTHER REPORTED THAT THE BOTTLES WERE LOOSE. THERE WAS NO PATIENT CONTACT. VERBATIM: ITEM(S): 2 BOTTLES ARE IN HUGH BOX WITH NO PACKING LOT(S):0001585577 DATE INCIDENT OCCURRED AND THE 27TH OF NOVERMBER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185948 ↗
• MalfunctionNov 5, 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. PRODUCT: INFORMATION ON THE ERROR PATTERN: FAULT LOCATION: ALCOHOL SWAB. ERROR TYPE: DRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605943 ↗
• MalfunctionOct 23, 2024Break; Break

  ACCESS TIP DAMAGED. MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO. NEEDLE/PROBE STICK: NO. OTHER ACTIONS TAKEN: NO. SAFETY ISSUE: NEIN. ISSUE RESOLVED: JA. HOW ISSUE RESOLVED / ADDITIONAL INFORMATION: REPLACEMENT. PHOTO / SAMPLE AVAILABLE: NEIN. SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED: NO. SAFETY CLAMP OPEN, WHEN VALVE BROKE/DAMAGED/DISCONNECTED: NO. SAFETY VALVE NOSE BROKEN / DAMAGED: NO. LOCKING TAB BROKEN / DAMAGED: NO. LEAKAGE: NO. SUCCESSFUL DRAINAGE: JA. IMPACT TO PATIENT: NO INDICATION FOR THAT / NOT APPLICABLE. EXPOSURE TO BLOOD / BODILY FLUID: NO. COURSE OF TREATMENT CHANGED DUE TO EVENT: NO. TIME CATHETER IN PLACE: SEE THE LIST. CONNECTED DEVICE (PLEURX/PERITX/BRAND) SEE THE LIST. PROCEDURE PERFORMED BY: END USER / LAY PERSON. ADDITIONAL INFORMATION: THE PALETTES ARE LOADED / STORED IN THE SAME WAY AS BD DELIVERS THEM. NO PALLETS ARE STACKED. WE DO NOT KNOW HOW THE BOTTLES ARE STORED AT THE PATIENT. (B)(6): (B)(6)2024: 1ST FOLLOW-UP COMMENTS (REC) COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? - NO VACUUM. WAS IT THE ACCESS TIP WAS CRACKED? - NOT KNOWN. WAS THE ISSUE IDENTIFIED BEFORE USE AND THE PRODUCT DISCARDED OR DID, THEY IDENTIFY DURING USE? - D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517918 ↗
• InjurySep 23, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD AN ALLERGIC REACTION TO THE DRESSING PAD FROM THE PLEURX KIT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED PATIENT STATED THAT SHE HAD AN ALLERGIC REACTION TO THE DRESSING PAD FROM THE PLEURX KIT. (NOTE: COMPLAINT WAS REPORTED BY THE PT ON AUG 27; HOWEVER, DUE TO AN OVERSIGHT THE COMPLAINT WAS NOT PROCESSED TIMELY). PRODUCT CODE -DB507510 - COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? HAVING TO USE MEDICAL TAPE, CUSTOMER REALIZED THAT IT WAS JUST A SKIN ALLERGY. - WHAT WAS THE IMPACT TO THE PATIENT? DISCOMFORT AND ITCHING - HAD TO BE PRESCRIBED ANTIBIOTICS. - COULD YOU PLEASE DESCRIBE AND INCLUDE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? I WAS PRESCRIBED ANTIBIOTICS. - HOW WAS THE ISSUE RESOLVED? YES IT HAS BEEN RESOLVED. I USE MEDICAL TAPE - WHERE IS THE CATHETER LOCATED? ABDOMEN OR CHEST - ON THE ABDOMEN MORE ON THE SIDE. - HOW LONG HAS THE CATHETER BEEN IN PLACE? I THINK (B)(6) 2024 - CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? NO - CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? CAN'T REMEMBER - I THINK A COU

  Patient problems: Itching Sensation

  MAUDE report 20286468 ↗
• MalfunctionJul 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT SO FAR, 6 OF THE 10 BOTTLES HAVE BEEN DEFECTIVE. THE BOTTLES ARE NOT SUCTIONING/DRAINING. THEY ALSO NOTED THE CAPS ARE NOT FITTING CORRECTLY EITHER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED AN EDGE PARK CUSTOMER RECEIVED A CASE OF PLUERX BOTTLES FOR HIS WIFE AND SO FAR, 6 OF THE 10 BOTTLES HAVE BEEN DEFECTIVE. THE BOTTLES ARE NOT SUCTIONING/DRAINING. HE ALSO NOTED THE CAPS ARE NOT FITTING CORRECTLY EITHER. CUSTOMER CALLED AND PROVIDED THE FOLLOWING INFORMATION. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? USING BOTTLES OVER A MONTH, SO NOT FIRST TIME, WHEN BOTTLE IS HOOKED AND PLUNGER IS PUSHED TO START SUCTION, NO SUCTION IS ACHIEVED, THE HOSE SOMEHOW IS COLLAPSED. 2. WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE BOTTLE? BOTTLE LOOKS FINE, NO DEFECT. 3. WAS THERE ANY INDICATION OR SOUND OF VACUUM ESCAPING? NO. 4. WHERE ARE THE BOTTLES STORED UNTIL USE? IN IT¿S ORIGINAL PACKAGING. 5. WAS THE CLAMP PROPERLY CLOSED UNTIL AFTER ACTIVATING THE SUCTION? YES IT WAS. 6. WERE THEY ABLE TO USE ANOTHER BOTTLE SUCCESSFULLY? YES 7. WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE CAP? SOME OF THE CAPS ARE OKAY, SOME AR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851409 ↗
• MalfunctionJun 5, 2024Unsealed Device Packaging; Unsealed Device Packaging

  INJURY (PATIENT / OTHER): NO. DEVICE POSSIBLY INVOLVED IN INJURY: NO. DEVICE AVAILABLE FOR EXAMINATION: YES. COMPLAINT: 0.3 PACKS HAVE ALREADY ARRIVED DAMAGED. ONE PACKET WAS ALREADY OPEN AT THE TOP AND THE TUBE WAS HANGING OUT. THE OTHER PACK WAS AS IF IT HAD "BURST OPEN". THIS MEANT THAT BOTH BOTTLES WERE PACKAGED NON-STERILE AND COULD NO LONGER BE USED. ADDITIONAL INFORMATION: DESCRIPTION OF THE PROBLEM (WHAT / WHY): PACKAGING BOTTLE DAMAGED. HOW MANY TIMES HAS THE DEFECT OCCURRED: 3. MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO. NEEDLE/PROBE STICK: NO. OTHER MEASURES TAKEN: NO. SAFETY ISSUE: NO. PROBLEM RESOLVED: YES. HOW THE PROBLEM WAS SOLVED / ADDITIONAL INFORMATION: REPLACEMENT. PHOTO / SAMPLES AVAILABLE: NO. SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED: NO. SAFETY CLAMP OPEN WHEN VALVE IS BROKEN/DAMAGED/CLAMPED OFF: NO. SAFETY VALVE NOSE BROKEN / DAMAGED: NO. LOCKING TAB BROKEN/DAMAGED: NO. LEAKAGE: NO. SUCCESSFUL EMPTYING: YES. EFFECTS ON THE PATIENT: NO INDICATION OF THIS / NOT APPLICABLE. EXPOSURE TO BLOOD / BODY FLUIDS: NO. COURSE OF TREATMENT CHANGED DUE TO THE EVENT: NO. CONNECTED DEVICE (PLEURX/PERITX/BRAND) 50-7510 PROCEDURE PERFORMED BY: END USER/ LAYPERSON. PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468403 ↗
• MalfunctionApr 26, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CALLED CUSTOMER ON (B)(6) 2024, IN ADDITION, THE ALCOHOLS WIPES HAVE BEEN FOUND DRY. SOMETIME IN OCTOBER LAST YEAR, (NO SPECIFIC DATE) AND ISSUE WAS NOT REPORTED TO EDGEPARK,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193740 ↗
• InjuryApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED: CUSTOMER HAD INFECTION EVENT DESCRIPTION STATES: - WHAT WAS THE IMPACT TO THE PATIENT? AFTER PT WAS NOT ABLE TO SUCTION MADE APPOINTMENT WITH DR, THEN DR SENT PT TO HOSPITAL, WHERE THEY WERE TREATED WITH IV ANTIBIOTICS TUBE WAS REMOVED AFTER IT WAS DETERMINED THAT THE INFECTION WAS CAUSED BY THE CATHETER IN PT WALL, PT WAS RELEASED 18TH MAR. CUSTOMER WAS CONTACTED REGARDING REPORTED ISSUE WITH PRODUCT RECEIVED FROM EDGE PARK DISTRIBUTORS, CUSTOMER REPORTED THAT AFTER VISITING THE DOCTOR REGARDING AN INFECTION AT CATHETER PLACEMENT SITE, DOCTOR ORDERED PATIENT ADMITTANCE INTO HOSPITAL FOR IV ANTIBIOTICS AND CATHETER REMOVAL. -WAS THERE INFECTION NOTICED AT THE INSERTION SITE? YES - WHAT WAS THE CAUSE OF THE INFECTION? CUSTOMER, FORMER RN SAID SHE FELT THAT IT WAS FROM THE DEVICE. - WAS THERE A LEAKAGE AT THE INSERTION SITE? YES, SHE SAID THERE WAS IN ADDITION TO REDNESS AND SWELLING - WAS THERE ANY DAMAGE NOTICED ON CATHETER VALVE? NO - WAS THERE ANY DAMAGE NOTICED ON THE CATHETER? NO - WAS THERE ANY ISSUE WITH THE PLEURX BOTTLE LEAD TO THE INFECTION? UNKNOWN - WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? YES, I

  Patient problems: Unspecified Infection

  MAUDE report 19043411 ↗
• MalfunctionJan 31, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: ¿HOLE IN TUBING¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615497 ↗
• MalfunctionDec 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT THERE¿S A SPLIT ON THE CONNECTOR THAT OPENED AN AIR HOLE WHICH DRAW AIR FROM OUTSIDE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THERE¿S A SPLIT ON THE CONNECTOR THAT OPENED AN AIR HOLE WHICH DRAW AIR FROM OUTSIDE. PER FOLLOW-UP: I CANNOT PROVIDE A SAMPLE AS THERE WAS BLOOD AND BODILY FLUID ON IT AND IT WAS DISPOSED. I PROVIDED THE LOT NUMBER TO THE REPRESENTATIVE AT MEDCONNECT/CARDINAL HEALTH. I NO LONGER HAVE THE PACKAGING. ALL OF THE INFORMATION RELATED TO THIS PRODUCT WAS ALREADY GIVEN TO THE CARDINAL HEALTH REPRESENTATIVE. FOLLOW UP: I CANNOT PROVIDE A SAMPLE AS THERE WAS BLOOD AND BODILY FLUID ON IT AND IT WAS DISPOSED. I PROVIDED THE LOT NUMBER TO THE REPRESENTATIVE AT MEDCONNECT/CARDINAL HEALTH. I NO LONGER HAVE THE PACKAGING. ALL OF THE INFORMATION RELATED TO THIS PRODUCT WAS ALREADY GIVEN TO THE CARDINAL HEALTH REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383646 ↗
• MalfunctionSep 19, 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: COULD NOT SCREW ON TUBE DEFECT. ADDITIONAL INFO FROM CUSTOMER: COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? CUSTOMER STATE THE CAP THAT YOU SNAP ON AFTER YOU ATTACHED THE BOTTLE WAS NOT WORKING. WAS THE DRAINAGE LINE DISCONNECTED FROM THE BOTTLE AT ANY POINT DURING THE DRAIN OR WAS IT NOTICED PRIOR TO DRAINAGE? NOTICED THIS ISSUE AFTER SHE WAS FINISHED DRAINING. IF IT IS BEFORE USE AND DID, THEY ATTEMPT TO RECONNECT IT? NEED TO VERIFY THE LINE WAS DISCONNECTED PRIOR TO USE AND THE BOTTLE WAS DISCARDED IMMEDIATELY, BOTTLE WAS NOT USED. BOTTLE WAS USED AND ONLY WAS ABLE TO PULL A LITTLE THEN DISCARDED THE BOTTLE. WAS THE CLAMP PROPERLY CLOSED UNTIL AFTER THE PLUNGER WAS PRESSED YES. WHERE IS THE CATHETER LOCATED? ABDOMEN OR CHEST ?ABDOMEN. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? IF YES, PLEASE PROVIDE MAILING ADDRESS AND EMAIL ADDRESS. NO. WHAT WAS THE IMPACT TO THE PATIENT? NO. WHAT IS THE NUMBER OF OCCURRENCE? NO. WHAT IS THE EVENT DATE? NO. ARE YOU ABLE TO IDENTIFY THE BATCH NUMBER? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775355 ↗
• MalfunctionJul 25, 2023Fracture; Fracture

  IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE. NO PATIENT HARM. EVENT DESCRIPTION STATES: CRACKED TUBING NO SUCTION 1 BOTTLE. QUESTIONS: - WAS IT THE ACCESS TIP THAT WAS CRACKED? TUBING OF THE BOTTLE AND LITTLE PLASTIC BEADS INSIDE THE TUBING. SO VACUUM WAS NOT WORKING, SEEMED AS IF IT WAS BLOCKED. - WAS THE DRAINAGE LINE CRACKED? - WAS THE CRACKED AND NO SUCTION ISSUE HAPPENED ON SAME BOTTLE? OR TWO DIFFERENT BOTTLES INVOLVED? ONE BOTTLE. - WAS THE ISSUE IDENTIFIED BEFORE USE AND THE PRODUCT DISCARDED OR DID, THEY IDENTIFY THE CRACK DURING USE? BEFORE USE. - IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? NO. - IF SAMPLE IS AVAILABLE, PLEASE ADVISE EMAIL AND ADDRESS FOR RETURN LABEL. NA. - ARE THEY ABLE TO DRAIN SUCCESSFULLY WITH THE NEW BOTTLE? HAD TO OPEN A NEW KIT. - WHAT IS THE LOT NUMBER? 0001507170. - WHERE IS THE CATHETER LOCATED? ABDOMEN OR CHEST ONE ON THE RIGHT AND ONE ON THE LEFT - WHAT WAS THE IMPACT TO THE PATIENT? - WERE THERE ANY SOUNDS OR HISSING? NO. - HOW WERE BOTTLES STORED BEFORE USE? KEEP THEM IN THE BOX STORED IN DINING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390627 ↗
• MalfunctionJul 25, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED BY THE CUSTOMER THAT 3EA OF KITS WERE OPENED AND UNABLE TO USE AS THEY WERE NO LONGER STERILE. VERBATIM: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: RN (B)(6) CALLED STATING PACKAGING OF 3EA OF KITS WERE OPENED SO NO LONGER STERILE UNABLE TO BE USED, SHE STATES DELIVERY BOX WAS NOT DAMAGED DURING TRANSIT, JUST PACKAGING OF KITS WAS NOT STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390218 ↗