BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER 0.1ML

    MDR report key: 11061718 · Received December 22, 2020

    Report

    Report Number
    3006948883-2020-01028
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 24, 2020
    Report Date
    January 12, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    PMA / PMN Number
    K933467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9231561. 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. UNFORTUNATELY DUE TO CURRENT PRACTICES BEING IMPLEMENTED BY CHINESE CUSTOMS USED MEDICAL DEVICE CANNOT BE SUBMITTED TO THE MANUFACTURING FACILITY FOR FUNCTIONAL TESTING. PHOTOGRAPHS OF THE DEVICES WERE SUBMITTED AND FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THE AFFECTED LOT. LEAKS WERE OBSERVED IN SOME OF THE RETENTION SAMPLES; CLOSER INSPECTION REVEALED THAT IN ALL INSTANCES WHERE A DEVICE HAD LEAKED THE HEPARIN CAP HAD BEEN INSERTED INTO THE CONNECTOR LOOSELY, REINSERTION OF THE HEPARIN CAP ALLOWED ALL OF THE DEVICES TO FUNCTION NORMALLY WITHOUT DEVELOPING FURTHER LEAKS. UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW; SUZHOU PLANT HAS INITIATED CAPA PR # 1474444 TO FURTHER INVESTIGATION OF THE DEFECT MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRN ADAPTER 0.1ML EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM THE CONNECTION BETWEEN THE ADAPTER (385110) AND IV CATHETER HAS BEEN FREQUENTLY OCCURRING. WE SUSPECT THAT THIS MAY BE ARISING FROM PRODUCT LOTS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRN ADAPTER 0.1ML EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM THE CONNECTION BETWEEN THE ADAPTER (385110), AND IV CATHETER HAS BEEN FREQUENTLY OCCURRING. WE SUSPECT THAT THIS MAY BE ARISING FROM PRODUCT LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523908 BD PRN ADAPTER 0.1ML INTERVASCULAR CATHETER FPA BD (SUZHOU) 9196787

    Patients

    Seq Age Sex Outcome Treatment
    1