PleurX 50-7000BRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10885403075971), received between Jun 2, 2021 and Sep 24, 2026 — classified as 1 death, 6 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876529 ↗
• MalfunctionJan 26, 2026Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT THE CHLOROPREP SWAB WAS LEAKING AT THE SEAL. A SECOND PROCEDURE TRAY HAD TO BE OBTAINED FROM THE STOCK ROOM. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE CHLORAPREP WAS UNOPENED AT THE TIME THE LEAK WAS DISCOVERED. NO VISUAL DAMAGE WAS OBSERVED UPON RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT EXPOSURE OR HARM REPORTED. THE ISSUE WAS DETECTED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185418 ↗
• MalfunctionJan 26, 2026Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT THE CHLOROPREP SWAB WAS LEAKING AT THE SEAL. A SECOND PROCEDURE TRAY HAD TO BE OBTAINED FROM THE STOCK ROOM. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE CHLORAPREP WAS UNOPENED AT THE TIME THE LEAK WAS DISCOVERED. NO VISUAL DAMAGE WAS OBSERVED UPON RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT EXPOSURE OR HARM REPORTED. THE ISSUE WAS DETECTED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185155 ↗
• MalfunctionJan 26, 2026Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT THE CHLOROPREP SWAB WAS LEAKING AT THE SEAL. A SECOND PROCEDURE TRAY HAD TO BE OBTAINED FROM THE STOCK ROOM. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE CHLORAPREP WAS UNOPENED AT THE TIME THE LEAK WAS DISCOVERED. NO VISUAL DAMAGE WAS OBSERVED UPON RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT EXPOSURE OR HARM REPORTED. THE ISSUE WAS DETECTED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185154 ↗
• MalfunctionMay 9, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED BY CUSTOMER THAT THEIR PLEURX CATHETER WOULD NOT FLUSH. VERBATIM: THEIR PLEURX CATHETER WOULD NOT FLUSH. THEY OPENED UP A NEW KIT WITH THE SAME LOT# AND IT WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998618 ↗
• InjuryDec 6, 2024Improper or Incorrect Procedure or Method; Defective Component; Improper or Incorrect Procedure or Method; Defective Component

  MATERIAL # 50-7000B. BATCH # UNKNOWN. IT WAS REPORTED THAT THE CATHETER WAS CONNECTED TO A BAG UTILIZING A STOPCOCK AND THE WEIGHT OF THE FLUID FILLED BAG PULLED THE CATHETER OUT OF THE PATIENT AND REQUIRING REPLACEMENT OF A NEW CATHETER. VERBATIM: - CATHETER WAS CONNECTED TO A BAG UTILIZING A STOPCOCK. - THE WEIGHT OF THE FLUID FILLED BAG PULLED THE CATHETER OUT. CUSTOMER RESPONSE ON (B)(6) 2024 FOR FOLLOW-UP 2. THIS IS WHAT THE CUSTOMER WAS ABLE TO ANSWER. WHITE CAP WOULD NOT ADAPT TO THE CATHETER NO HARM TO PATIENT, HOWEVER, WAS CHARGED FOR A FULL KIT IN ORDER TO GET ANOTHER WHITE CAP NO INJURY I DO NOT HAVE A LOT NUMBER, INCLUDING MARY LYNN HERE IN CASE SHE HAS THAT INFORMATION. ¿HI¿I DO NOT HAVE THE LOT INFORMATION; BASICALLY, NURSING WAS HAVING TO OPEN UP A WHOLE KIT AS THE WHITE CAP WAS BROKEN¿. CUSTOMER RESPONSE ON (B)(6) 2024. WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE CAP? THE WHITE CAP WOULD NOT ATTACH TO THE CATHETER. UNCERTAIN IF VISIBLE DAMAGE WAS NOTICED. DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? THIS HAPPENED WHEN ATTEMPTING TO ATTACH A CAP TO A PATIENTS CA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859817 ↗
• MalfunctionOct 23, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED BY CUSTOMER THAT 2 EACH OF ITEM: 50-7000B HAD WATER DAMAGE WHEN DELIVERED. RCC RECEIVED A COMPLAINT VIA COMMUNITY. THE CUSTOMER CALLED IN AND REPORTED THAT ITEM 2 EACH OF ITEM: 50-7000B HAD WATER DAMAGE WHEN DELIVERED. THEY ARE REQUESTING A RETURN AND CREDIT. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? ITEM SHOWS WATER STAINS ON THE PACKAGE. 2. WHAT WAS THE IMPACT TO THE PATIENT? NO. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 4. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? 0001582626. 5. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2024. 6. ARE YOU ABLE TO PROVIDE PHOTOS OF THE DAMAGED ITEMS? YES. 7. CAN YOU DESCRIBE THE EXTERNAL CONDITION OF THE BOX UPON RECEIPT, ANY SIGNS OF MISHANDLING? I CAN NOT. 8. DID YOU NOTICE ANY UNUSUAL SOUNDS OR SHIFTING INSIDE THE BOX WHEN HANDLING IT? NO. 9. CAN YOU DESCRIBE ANY DAMAGE FOUND TO THE ITEMS INSIDE (INCLUDING QUANTITY/CASES/SHELF PACK AFFECTED?) NO, WE DID NOT OPEN THE PRODUCT. 10. COULD YOU PLEASE CONFIRM IF THERE IS ANY ISSUE WITH PRODUCT OR THIS IS A SERVICE ISSUE? I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516245 ↗
• MalfunctionApr 16, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY CUSTOMER THAT RUSTY SCISSORS. VERBATIM RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED REF: 50-7000B; LOT: 0001539010. ISSUE: CUSTOMER REPORTED RUSTY SCISSORS. PT HARM: NO. SAMPLE: YES. CUSTOMER IS REQUESTING REPLACEMENT OF FOUR ITEMS. CUSTOMER RESPONSE ON APRIL 11, 2024 IN RESPONSE TO YOUR INQUIRY, PLEASE SEE THE BELOW: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? MARCH 26, 2024. 2. HOW ARE THE PRODUCTS STORED UNTIL USE? STORED IN THE CUSTOMER'S OFFICE. 3. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? BEFORE USE, DURING PREP FOR THE PROCEDURE. 4. SAMPLE AVAILABLE IS MENTIONED AS YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES, SAMPLE AVAILABLE. CUSTOMER ADVISED THEY HAVE 1EA THAT WAS AFFECTED AND AN ADDITIONAL 3EA FROM THE SAME LOT NUMBER. CUSTOMER IS REQUESTING TO RETURN/CREDIT ALL 4 EA AS THEY ARE WARY TO USE PRODUCT FROM THE SAME LOT NUMBER AS THE AFFECTED ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119277 ↗
• InjuryNov 21, 2023Break; Break

  IT WAS REPORTED BY CUSTOMER THAT WHAT HE DESCRIBED AS A PRODUCT FAILURE. HE REPORTS THAT A PATIENT CAME INTO THE IR ON 11/3 FOR THE INSPECTION OF A CLOGGED PLEURX CATHETER. WHILE THE PHYSICIAN ATTEMPTED TO CHANGE OUT THE CATHETER, THE CATHETER BROKE, AND 6 INCHES OF THE LINE REMAINED IN THE PATIENT. AS A RESULT, SURGERY WAS REQUESTED, AND THE PATIENT HAD A PROCEDURE TO REMOVE THE REMAINING PORTION OF THE CATHETER. THE CUSTOMER REPORTS THAT THEY STILL HAVE THE PIECE THAT BROKE OFF IN THE PATIENT. THE CATHETER WAS ORIGINALLY INSERTED ON (B)(6) 2023. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INQUIRY VIA SHARIEKA HIGHT. CUSTOMER IS REPORTING WHAT HE DESCRIBED AS A PRODUCT FAILURE. HE REPORTS THAT A PATIENT CAME INTO THE IR ON 11/3 FOR THE INSPECTION OF A CLOGGED PLEURX CATHETER. WHILE THE PHYSICIAN ATTEMPTED TO CHANGE OUT THE CATHETER, THE CATHETER BROKE AND 6 INCHES OF THE LINE REMAINED IN THE PATIENT. AS A RESULT SURGERY WAS REQUESTED AND THE PATIENT HAD A PROCEDURE TO REMOVE THE REMAINING PORTION OF THE CATHETER. THE CUSTOMER REPORTS THAT THEY STILL HAVE THE PIECE THAT BROKE OFF IN THE PATIENT. THE CATHETER WAS ORIGINALLY INSERTED ON (B)(6) 2023. CUSTOMER RESP

  Patient problems: Foreign Body In Patient

  MAUDE report 18186724 ↗
• MalfunctionOct 4, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT MD AXXX HAD A CUT IN THE NEW CATHETER BY THE CUFF AND THEN THEY PULLED A NEW ONE AND THEN IT HAD A BROKEN VALVE. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I HAVE 2 PRODUCT COMPLAINTS ON PLEURX. MD AXXX HAD A CUT IN THE NEW CATHETER BY THE CUFF AND THEN THEY PULLED A NEW ONE AND THEN IT HAD A BROKEN VALVE. THEY THEN REPLACED THE VALVE ON THAT CATHETER AND IT WAS FINE. THE HCP WAS DISCOURAGED BECAUSE HE FELT THE CUT IN THE CATHETER STARTED A NEUMO. I DO HAVE BOTH IN MY POSSESSION TO SEND IN TO QUALITY. PLEASE SEND ME INFORMATION NEEDED TO SEND BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868151 ↗
• InjuryOct 4, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT MD AXXX HAD A CUT IN THE NEW CATHETER BY THE CUFF AND THEN THEY PULLED A NEW ONE AND THEN IT HAD A BROKEN VALVE. VERBATIM: I HAVE 2 PRODUCT COMPLAINTS ON PLEURX. MD AXXX HAD A CUT IN THE NEW CATHETER BY THE CUFF AND THEN THEY PULLED A NEW ONE AND THEN IT HAD A BROKEN VALVE. THEY THEN REPLACED THE VALVE ON THAT CATHETER AND IT WAS FINE. THE HCP WAS DISCOURAGED BECAUSE HE FELT THE CUT IN THE CATHETER STARTED A NEUMO. I DO HAVE BOTH IN MY POSSESSION TO SEND IN TO QUALITY. PLEASE SEND ME INFORMATION NEEDED TO SEND BACK.

  Patient problems: Pneumothorax

  MAUDE report 17868150 ↗
• InjuryJun 26, 2023Leak/Splash; Leak/Splash

  EVENT DESCRIPTION STATES: LEAKAGE. CUSTOMER PUT IN THE CATHETER ABOUT A MONTH AGO ON 05/17, IT HAD BEEN WORKING PERFECTLY FINE. THEN, THERE WAS A BIT OF LEAKING AROUND IT, SHE PUT A PURSE STRING SUTURE AROUND IT, AND NOW THE CATHETER IS NOT DRAINING AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199848 ↗
• DeathApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ONE- IT WAS REPORTED BY THE CUSTOMER THAT A PORTION ON THE CATHETER BROKE OFF AND REMAINED IN THE PLEURAL CAVITY. VERBATIM: PER OUR CONVERSATION EARLIER TODAY WE HAVE HAD TWO SEPARATE INCIDENTS INVOLVING THE PLUREX CATHETERS, SPECIFIC TO THEIR REMOVAL. ON TWO SEPARATE PATIENTS (IN TWO DIFFERENT HOSPITAL LOCATIONS) WE HAD A PORTION OF THE CATHETER BREAK OFF AND REMAIN IN THE PLEURAL CAVITY. ONE PATIENT WAS END OF LIFE AND IT WAS DECIDED THE OUTCOME WAS NOT WORTH THE RISK AND IT WAS LEFT IN THE PATIENT. THE OTHER PATIENT DID HAVE TO HAVE THE CATHETER SURGICALLY REMOVED. PER EMAIL 04/11/2023 : PLEASE ANSWER THE FOLLOWING QUESTIONS: WERE ANY SAMPLES AND/OR PICTURES OF THE ISSUE AVAILABLE? NO, BOTH PRODUCTS WERE DISPOSED OF . HOW LONG DID THE PATIENTS HAVE THE CATHETERS IN PLACE? IS THE LOT NUMBER AVAILABLE FOR THE OTHER DEVICE? THE OTHER DEVICE WAS NOT PLACED AT OUR FACILITY SO WE DO NOT HAVE THE LOT# FOR IT IS THE DATE OF EVENTS AVAILABLE? BOTH HAPPENED ON 4/3. THERE WAS A MENTION THAT IT HAPPENED AT TWO HOSPITALS, IS THE NAME OF THE OTHER FACILITIES AVAILABLE? ONE HAPPENED AT OUR MAIN CAMPUS AND THE OTHER AT OUR (B)(6). LOT NUMBER ASSOCIATED WITH PATIENT NUMBER ONE AND NUMBER

  Patient problems: Foreign Body In Patient

  MAUDE report 16826257 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT 2: IT WAS REPORTED BY THE CUSTOMER THAT A PORTION ON THE CATHETER BROKE OFF AND REMAINED IN THE PLEURAL CAVITY. VERBATIM: PER OUR CONVERSATION EARLIER TODAY WE HAVE HAD TWO SEPARATE INCIDENTS INVOLVING THE PLUREX CATHETERS, SPECIFIC TO THEIR REMOVAL. ON TWO SEPARATE PATIENTS (IN TWO DIFFERENT HOSPITAL LOCATIONS) WE HAD A PORTION OF THE CATHETER BREAK OFF AND REMAIN IN THE PLEURAL CAVITY. ONE PATIENT WAS END OF LIFE AND IT WAS DECIDED THE OUTCOME WAS NOT WORTH THE RISK AND IT WAS LEFT IN THE PATIENT. THE OTHER PATIENT DID HAVE TO HAVE THE CATHETER SURGICALLY REMOVED. PER EMAIL 04/11/2023. PLEASE ANSWER THE FOLLOWING QUESTIONS: ¿ WERE ANY SAMPLES AND/OR PICTURES OF THE ISSUE AVAILABLE? ¿ NO, BOTH PRODUCTS WERE DISPOSED OF. ¿ HOW LONG DID THE PATIENTS HAVE THE CATHETERS IN PLACE? ¿ IS THE LOT NUMBER AVAILABLE FOR THE OTHER DEVICE? ¿ THE OTHER DEVICE WAS NOT PLACED AT OUR FACILITY SO WE DO NOT HAVE THE LOT# FOR IT. ¿ IS THE DATE OF EVENTS AVAILABLE? ¿ BOTH HAPPENED ON 4/3. ¿ THERE WAS A MENTION THAT IT HAPPENED AT TWO HOSPITALS, IS THE NAME OF THE OTHER FACILITIES AVAILABLE? ONE HAPPENED AT OUR MAIN CAMPUS AND THE OTHER AT OUR (B)(6). - LOT NUMBER ASSOCIATED WITH PATIENT NUMBER

  Patient problems: Foreign Body In Patient

  MAUDE report 16825345 ↗
• MalfunctionJan 18, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT VALVE IS CRACKED ON CATHETER. VERBATIM: TM STATES SHE JUST RECEIVED A CALL FROM A CUSTOMER STATING THEY HAVE A PATIENT WITH A CRACKED END VALVE ON THEIR PLEURX CATHETER. 05-JAN-2023: THIS IS NOT A QUALITY ISSUE APPARENTLY THE PATIENT BROKE THE VALVE, IT WASN¿T A PRODUCT MALFUNCTION. PLEASE DISREGARD. ADDITIONAL INFORMATION RECEIVED 19-JAN-2023 ¿ WHAT IS THE DATE OF EVENT? (B)(6) 2023 ¿ WHAT IS THE MAT AND LOT NUMBER? 50-7000B ¿ NO LOT INFO ¿ WAS THE ISSUE NOTICED BEFORE OR DURING USE? DURING WHILE CAP WAS BEING PUT ON, JUST A CHIPPED TIP NOT A BROKEN VALVE ¿ WAS THERE ANY PATIENT HARM/IMPACT? IF SO WAS THERE A NEED FOR ANY MEDICAL TREATMENT OR INTERVENTION? NO HARM ¿ WAS THERE LEAKAGE NOTICED AT THE CATHETER VALVE? NO ¿ WHERE IS THE CATHETER LOCATED? ABDOMEN OR CHEST LEFT CHEST ¿ HOW LONG HAS THE CATHETER BEEN IN PLACE ¿ NOT SURE ¿ HOW WAS THE ISSUE RESOLVED? REPLACEMENT VALVE ¿ WHAT IS THE FULL NAME AND ADDRESS OF THE FACILITY FOR WHERE THE ISSUE OCCURRED? OMITTED ¿ DO YOU HAVE ANY PHOTOS TO SHOW THE REPORTED ISSUE? NO ¿ DO YOU HAVE A SAMPLE TO SEND IN FOR EVALUATION? NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194726 ↗
• MalfunctionNov 29, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DEVICE HAD DEFECTIVE/DAMAGED PIECE AND UNABLE TO DRAIN. VERBATIM: INSIDE THE KIT THERE IS A CONNECTION TUBING, THERE IS A ¿CHRISTMAS¿ TREE CONNECTOR AND IT WAS COMPLETED BLOCK. IT WAS JUST A PIECE OF SOLID PLASTIC. IT WOULD NOT DRAIN. THERE WAS NO PATIENT IMPACT BUT SHE DID STATE THE PATIENT HAD TO STAY IN THE OPERATING ROOM FOR AN EXTRA 30 MINUTES. (B)(6) 2022: WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED: PLEURX CATHETER PLACEMENT. WAS THERE A NEED TO REPEAT THE PROCEDURE? NO, BUT IT WAS CLOSE TO THAT. HOW WAS THE ISSUE RESOLVED? WE DISCONNECTED THE PLEURX FROM THE CONNECTION TUBING AND REALIZED THAT THE CHRISTMAS TREE CONNECTOR WAS NOT PATENT. WE EXCHANGED A NEW ONE AND IT WAS FUNCTIONING AFTERWARDS. WHAT IS THE REF/MATERIAL NUMBER OF THE PRODUCT? 50-7000B IS THE CATALOG NUMBER. WHAT IS THE LOT NUMBER OF THE PRODUCT? DO NOT KNOW. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? I HAVE ATTACHED THE PHOTO. WERE THEY ABLE TO COMPLETE THE DIAGNOSIS CORRECTLY? THE PROCEDURE WAS COMPLETED, BUT WAS ABOUT 40 MINUTES EXTRA OF PROCEDURE TIME TRYING TO TROUBLESHOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883649 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT PLEURX CATHETERS TEAR DURING THE REMOVAL OF THE CATHETER AND THE CATHETER COMPLETELY RIPPED APART AT THE AREA PROXIMAL TO THE CUFF. VERBATIM: OVER THE LAST YEAR WE HAVE HAD MORE PLEURX CATHETERS TEAR DURING THE REMOVAL OF THE CATHETER. WE HAVE BEEN PUTTING THESE IN FOR MORE THAN 15 YEARS AND NEVER HAD THIS ISSUE BEFORE. TODAY THE CATHETER COMPLETELY RIPPED APART AT THE AREA PROXIMAL TO THE CUFF. WE HAD TO USE A SCALPEL TO GET THE CATHETER OUT AND THEN SUTURES TO CLOSE UP THAT AREA. (B)(6) 2022: THE TUBE IS NORMALLY VERY EASY TO GET OUT. THEY HAVE BECOME INCREASINGLY MORE FRAGILE AND IN BREAKING OFF MORE DIFFICULT TO REMOVE. NO PHOTOS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595209 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT PLEURX CATHETERS TEAR DURING THE REMOVAL OF THE CATHETER AND THE CATHETER COMPLETELY RIPPED APART AT THE AREA PROXIMAL TO THE CUFF. VERBATIM: OVER THE LAST YEAR WE HAVE HAD MORE PLEURX CATHETERS TEAR DURING THE REMOVAL OF THE CATHETER. WE HAVE BEEN PUTTING THESE IN FOR MORE THAN 15 YEARS AND NEVER HAD THIS ISSUE BEFORE. TODAY THE CATHETER COMPLETELY RIPPED APART AT THE AREA PROXIMAL TO THE CUFF. WE HAD TO USE A SCALPEL TO GET THE CATHETER OUT AND THEN SUTURES TO CLOSE UP THAT AREA. (B)(6) 2022: THE TUBE IS NORMALLY VERY EASY TO GET OUT. THEY HAVE BECOME INCREASINGLY MORE FRAGILE AND IN BREAKING OFF MORE DIFFICULT TO REMOVE. NO PHOTOS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595207 ↗
• InjurySep 20, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED BY THE CUSTOMER THAT THE PIECE FROM THE PRODUCT WAS NOT PATENT . VERBATIM: AN INCIDENT THAT HAPPENED AROUND 5 PM, AFTER SURGERY REGARDING A PATIENT. THE FELLOW CAME TO THE SURGERY FRONT DESK AND INFORMED OF AN INCIDENT. PATIENT HAD A TENSION PNEUMO FOLLOWING HIS VIDEO ASSISTED THORACOTOMY WITH A PLEURAX PLACEMENT. A WHITE CONNECTOR PIECE FROM THE KIT WAS NOT PATENT. HE WAS TROUBLE SHOOTING THE SYSTEM AT THE PATIENT'S BEDSIDE OF WHY THE CATHETER WAS NOT WORKING PROPERLY. WHEN HE DISASSEMBLE THE SETUP, HE NOTICED THE PIECE FROM THE KIT WAS NOT PATENT. THIS PIECE WAS IMMEDIATELY REMOVED AND CHANGED AND THEN THE CATHETER WAS WORKING PROPERLY. THE FELLOW BROUGHT THE CONNECTOR BACK TO THE OPERATING ROOM FOR THE SURGICAL SERVICES TO FOLLOW UP. I CALLED SICU TO CHECK ON THE PATIENT HE WAS STABLE AND DOING WELL. THE LOT NUMBER OF THE INSERTED CATHETER IS 0001471891 WE HAD 2 IN THE SURGICAL UNIT THAT WERE PULLED, AND MATERIALS MANAGEMENT WAS NOTIFIED OF THE LOT NUMBER TO PULL AND RETAIN ALL UNITS TO SWAP OUT FOR DIFFERENT KITS. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Pneumothorax

  MAUDE report 15456230 ↗
• MalfunctionJul 22, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT CUSTOMER RECEIVED OPENED PACKAGING. VERBATIM: PI-IS- VERBATIM: WE HAVE FOUND 3 PLEURX CATH REF 50-7000B ¿ THE STERILIZATION WRAP HAS A SMALL TEAR ( ON ALL 3 ) ALL IN THE SAME CORNER. THE OUTER WRAP IS NOT EFFECTED. THEY COULDN¿T USE THEM, DUE TO INTEGRITY. THEY EXPIRE TODAY 6/30/22. PATIENT HAD DELAYED TREATMENT AND HCP HAD TO OPEN NEW PACKS AND AVOID USING THESE 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084707 ↗
• MalfunctionJul 8, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT CUSTOMER REPORTED KIT WAS MISSING NEEDLE AND THE CAP AND THE VALVE WAS BENT/DEFECTIVE. VERBATIM: PI-IS- VERBATIM: I WAS OUT HALF OF LAST WEEK BUT WHEN I CAME BACK TODAY MY TEAM MEMBERS SAID THEY HAD SOME ISSUES WITH ONE OF THE PLEURAL PLEURX KITS. THE TRAY WAS MISSING THE NEEDLE ( TO PLACE DRAIN) AND THE CAP ( WE HAVE SPARES SO THEY JUST DROPPED ONE). THEY MENTIONED THAT THE CONNECTION VALVE TO THE PLEURX ITSELF WAS BENT OF SOME SORT? UNFORTUNATELY IT WAS NOT REALIZED UNTIL IT WAS ALREADY PLACED, THEY WERE STILL ABLE TO DRAIN THE PATIENT THANK GOODNESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14956570 ↗
• MalfunctionMay 26, 2022Difficult to Insert; Difficult to Insert

  I WAS REPORTED THAT VALVE ON TUBING MAY BE DEFECTIVE - NOT CLICKING IN PLACE. VERBATIM: "...I HAVE A DIFFERENT ISSUE THAT I WANT TO REPORT. THIRD CASE NOW: I HAVE NOTICED THAT DRAINAGE KIT INCLUDED IN PLEURX KIT DOES NOT CLICK WITH PLEURX TUBING. THIS LOOKS LIKE A MANUFACTURING PROBLEM. WE HAVE BEEN USING SEPARATE PLEURX DRAIN BOTTLES TO DRAIN KIT. CAP STILL GOES ON NICELY BUT CONNECTION KIT DOES NOT. HAVE YOU HEARD THIS FROM OTHER PHYSICIANS OR I AM THE ONLY ANOMALY HERE? "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515814 ↗
• MalfunctionMay 20, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED BY CUSTOMER THAT CATHETER POPPED OFF DURING FLUSH. VERBATIM: ATTEMPTING TO DE-CLOG PATIENT'S EXISTING PLEURX CATHETER BY FLUSHING WITH STERILE WATER THROUGH A CONNECTED PLEURX LOCKABLE DRAINAGE LINE AND THE CONNECTOR ON THE PLEURX CATHETER POPPED OFF DURING FLUSH. SLIDE CLAMP FROM LOCKABLE DRAINAGE LINE KIT IMMEDIATELY APPLIED. THORACENTESIS THEN PERFORMED FOR PATIENT TO DRAIN PLEURAL EFFUSION AND PLEURX CATHETER WAS REMOVED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : ATTEMPTING TO DE-CLOG PATIENTS EXISTING PLEURX CATHETER BY FLUSHING WITH STERILE WATER. WHAT WAS THE IMPACT TO THE PATIENT? NO. WHERE IS THE CATHETER LOCATED? DISCARDED . WAS THE PLEURX CATHETER OCCLUDED? ATTEMPT WAS MADE TO IRRIGATE THE CATHETER FOR POSSIBLE TPA. THIS IS WHEN THE VALVE CAME COMPLETELY OFF THE TUBING. WAS THE CLAMP OPEN DURING THE REPORTED ISSUE " DISCONNECTED CATHETER VALVE FROM THE CATHETER? THE CLAMP WAS NOT ON THE CATHETER DURING THESE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458641 ↗
• MalfunctionJul 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL NO: 50-7000B. BATCH NO: 0001402210.   IT WAS REPORTED THAT THE DILATOR AND PEEL-AWAY INTRODUCER DID NOT LOCK IN PLACE PRIOR TO INSERTION INTO THE PATIENT'S CHEST AND HAD TO BE IMMEDIATELY REMOVED.   VERBATIM: DESCRIBE THE EVENT OR PROBLEM: THE DILATOR AND PEEL-AWAY INTRODUCER WAS FAULTY. IT DID NOT LOCK IN PLACE PRIOR TO INSERTION INTO THE PATIENT'S CHEST. IT IMMEDIATELY HAD TO BE REMOVED. THERE IS A PIECE THAT LOCKS THE DILATOR IN PLACE AND IT IS MISSING ON THIS ITEM. THIS IS AN ITEM THAT IS NOT PACKAGED SEPARATELY SO A NEW KIT HAD TO BE OPENED WHILE THE PATIENT'S CHEST HAD ALREADY BEEN INCISED IN PREPARATION FOR CATHETER INSERTION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : INDWELLING PLEURAL CATHETER PLACEMENT. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; 29JUN21 - LVM REQUESTING CLARIFICATION OF DEFECTIVE ISSUE - LEFT CONTACT INFORMATION. 01JUL21 - SENT ACK EMAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142600 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED THAT THE THORACIC SURGEON PLACED A PLEURX CATHETER IN A PATIENT - THE CATHETER DISCONNECTED FROM THE DRAINAGE LINE DUE TO THE LOCKABLE TIP / ACCESS TIP FALLING OFF OF THE TUBING / DRAINAGE LINE.   VERBATIM: ...THORACIC SURGEON, PLACED A PLEURAL CATHETER, 50-7000B IN A PATIENT. THE CATHETER WAS THEN ATTACHED TO THE DRAINAGE LINE WITH LOCKABLE ACCESS TIP. THE END OF THIS DRAINAGE LINE THAT WAS INSERTED INTO OUR VALVE ON THE END OF THE PLEURX CATHETER DISCONNECTED FORM THE TUBING OF THE LINE. THE ACTUAL HARD PLASTIC LOCKABLE TIP FELL OFF OF THE TUBING. I WILL BE IN THE OR TO MEET WITH HIM THIS COMING MONDAY MORNING (B)(6) 2021 TO REVIEW IN PERSON THESE DETAILS. HE GAVE ME LOT# 0001392995 FOR THE 50-7000B PRODUCT. THE LINE WAS REPLACED IMMEDIATELY BY THE SURGEON BY ACCESSING ANOTHER PLEURX TRAY TO GET A STERILE DRAINAGE LINE FROM THAT TRAY TO USE. THE CONNECTIONS ON THE ONE HE ACCESSED WERE SECURE. RESPONSE EMAIL - I DID MEET WITH DR. (B)(6) YESTERDAY MORNING PER THE REPORT ABOVE. I VERIFIED THAT IT WAS THE TUBING SEPARATING FROM ITS LUER LOCK PLASTIC CONNECTOR. HE HAD THE LINES BAGGED FOR US BUT THEN THE NURSE IT WAS HANDED OFF TO HAD THROWN THEM AWAY MUCH TO HIS AGGRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922924 ↗