BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRN ADAPTER

    MDR report key: 10300070 · Received July 20, 2020

    Report

    Report Number
    3006948883-2020-00302
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    May 23, 2020
    Report Date
    August 12, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    DRS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9140768. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT. THE UNITS WERE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRN ADAPTER EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HEPARIN CAP RUPTURE WAS FOUND AT THE HEPARIN CAP JUNCTION ABOUT 1 HOUR AFTER FLUID INFUSION ON THE SECOND DAY AFTER PICC IMPLANTATION. THE DRESSING, HEPARIN CAP AND NORMAL SALINE FLUSHING TUBE WERE REPLACED. THE NURSE HAD REPORTED IT TO CHIEF. NO ADVERSE CONSEQUENCES HAVE BEEN FOUND FOR THE CHILDREN.

    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 PRN ADAPTER EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HEPARIN CAP RUPTURE WAS FOUND AT THE HEPARIN CAP JUNCTION ABOUT 1 HOUR AFTER FLUID INFUSION ON THE SECOND DAY AFTER PICC IMPLANTATION. THE DRESSING, HEPARIN CAP AND NORMAL SALINE FLUSHING TUBE WERE REPLACED. THE NURSE HAD REPORTED IT TO CHIEF. NO ADVERSE CONSEQUENCES HAVE BEEN FOUND FOR THE CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764202 PRN ADAPTER LUER LOK ADAPTER DRS BD (SUZHOU) 9140768

    Patients

    Seq Age Sex Outcome Treatment
    1 Other