N/A 50-7280ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403502408), received between Apr 19, 2023 and Apr 19, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE CUSTOMER THE NURSE FELT RESISTANCE WHEN USING THE DEVICE AND ALSO NOTICED A YELLOW DEPOSIT. VERBATIM: PRIOR TO (B)(6) 2023, THE NURSE USED THE DEVICE, THAT IS WHEN SHE NOTICED IT WAS MORE DIFFICULT TO USE AND SHE NOTICED THE YELLOW DEPOSIT. I DO NOT HAVE A DATE FOR THE FIRST EVENT AND I CANNOT TRACK THE PATIENT. IN BOTH INSTANCES ON SEPARATE WEEKS, THE DEVICE WAS USED FOR PATIENT CARE. BOTH INSTANCES WE CANNOT IDENTIFY THE PATIENT. (B)(6) 2023 INCIDENT DOCUMENTED UNDER PR 7584005 . ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL WITH CUSTOMER (B)(6) 2023 SPOKE WITH CUSTOMER AS SHE CALLED TO FOLLOW UP PER OUR EMAIL RECEIVED, WE SPOKE AT LENGTH AND SHE PROVIDED THE FOLLOWING DETAILS. THE RESISTANCE CUSTOMER EXPERIENCED WAS GETTING THE ACCESS TIP FITTED INTO THE CATHETER VALVE, IT WAS MORE DIFFICULT TO PUT THE ACCESS TIP INTO THE VALVE BUT THEY WERE ABLE TO EVENTUALLY GET IT CONNECTED AND DID NOT EXPERIENCE ANY LEAKING AND THERE WAS NO PATIENT IMPACT. THERE WERE NO SUCTION ISSUES. SIMILAR ISSUE WAS REPORTED WITH THIS PR AS WE DON'T HAVE PHOTOS-PROVIDED PIC IS OF THE ACCESS TIP. YELLOW DEPOSITS OBSERVED ON ACCESS TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770444 ↗
• MalfunctionApr 19, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE CUSTOMER THAT PRODUCT SHOWS A YELLOWISH DEPOSIT WHEN REMOVED FROM ITS STERILE PACKAGING. HERE ARE THE DETAILS. LOT#: 0001475174 FOR THE PLEURX ACCES KIT APPEARS TO BE DEFECTIVE (YELLOW DEPOSIT AND RESISTANCE WHEN CONNECTING TO THE DRAIN). PLEASE MAKE SURE THE UNITS AT THE MUHC DO NOT RECEIVE THAT LOT ANYMORE (I DON'T WHERE IT COMES FROM WHEN THE STOREKEEPER RESTOCKS OUR CARTS). CAN WE GET REPLACEMENT PRODUCTS (OR A CREDIT) FROM A DIFFERENT LOT TO COMPENSATE FOR THE (B)(4) ITEMS (4 BOXES OF 5) I HAD TO REMOVE FROM CIRCULATION ON THE UNIT. WHAT IS THE DATE OF EVENT? WEDNESDAY APRIL 22RD 2023. THERE WAS A LOT NUMBER PROVIDED OF 0001475174 AND ANOTHER LOT NUMBER SHOWN ON THE PHOTO OF THE PACKAGING WHICH IS 0001478174. CAN YOU PLEASE RE CHECK THE LOT NUMBER? THE LOT NUMBER: 0001475174 WAS NOT FOUND WITHIN OUR SYSTEM BUT WE WERE ABLE TO LOCATE 0001478174. CORRECT LOT NUMBER IS 0001478174 AS SHOWN ON THE PACKAGING WAS THE ISSUE FOUND PRIOR TO USE OR WAS THERE ANY USE ON PATIENT? IF SO WAS THERE ANY IMPACT OR HARM DUE TO THE REPORTED ISSUE? YES, THE ISSUES WAS FOUND PRIOR TO USE AND THERE WERE USE ON 2 SEPARATE PATIENTS. NURSES FOUND THERE WAS MORE RESISTANCE TO WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769185 ↗