BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTOR

    MDR report key: 17143604 · Received June 16, 2023

    Report

    Report Number
    9616066-2023-01194
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 9, 2023
    Report Date
    September 7, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    UDI-DI
    00382903886388
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2222245. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE. IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PRN ADAPTOR THE CAP WAS DAMAGED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: 2023.5.9 THE PATIENT UNDERWENT LAPAROSCOPIC OVERNIGHT INDWELLING NEEDLE TO PLACE A NEW HEPARIN CAP, BUT THE LIQUID STILL LEAKED AFTER TIGHTENING, AND THE CAP WAS USED NORMALLY, AND NO ADVERSE EVENTS WERE CAUSED TO THE PATIENT AFTER REPLACEMENT OF ANOTHER HEPARIN CAP. MATERIAL# INFORMATION UPDATED ACCORDING TO CAT# & LOT# LIST PROVIDED BY SUZHOU PLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PRN ADAPTOR THE CAP WAS DAMAGED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: (B)(6)2023THE PATIENT UNDERWENT LAPAROSCOPIC OVERNIGHT INDWELLING NEEDLE TO PLACE A NEW HEPARIN CAP, BUT THE LIQUID STILL LEAKED AFTER TIGHTENING, AND THE CAP WAS USED NORMALLY, AND NO ADVERSE EVENTS WERE CAUSED TO THE PATIENT AFTER REPLACEMENT OF ANOTHER HEPARIN CAP. MATERIAL# INFORMATION UPDATED ACCORDING TO CAT# & LOT# LIST PROVIDED BY SUZHOU PLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187983 BD PRN ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA BD (SUZHOU) 2222245 00382903886388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown