BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 12337922 · Received August 18, 2021

    Report

    Report Number
    1911916-2021-00842
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    June 29, 2021
    Report Date
    August 9, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 15 JULY, 2021. MEDWATCH REPORT # MW5102292. REPORT SOURCE OTHER: MEDWATCH REPORT. INVESTIGATION SUMMARY: IT WAS REPORTED A HAIR WAS WITHIN THE SYRINGE ATTACHED TO THE BASE OF THE PLUNGER. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE RECEIVED IS ONLY THE PLUNGER ROD WITH THE RUBBER STOPPER. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 1112977. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE GOWNING PROCESS HAS BEEN REVIEWED WITH ASSOCIATES AND MONITORING IS COMPLETED TO ASSURE PROPER GOWNING IS PERFORMED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: PROBABLE ROOT CAUSE. BASED ON THE VISUAL INSPECTION THE FOREIGN MATTERS APPEARS TO BE PARTIALLY EMBEDDED IN THE RUBBER STOPPER. THE SAMPLE WILL BE SENT TO A LABORATORY FOR FURTHER ANALYSIS. THE GOWNING PROCESS HAS BEEN REVIEWED. MONITORING THAT PROPER GOWNING IS PERFORMED. THE LABORATORY ANALYSIS CONFIRMED A FIBER; HOWEVER, THE RESULTS WERE INCONCLUSIVE ON THE TYPE OF FIBER. A FLUSH TEST WAS ALSO PERFORMED, AS A WAY TO ASSESS THE RISK THIS FIVER COULD BE EXPELLED. THE FIBER STAYED INSIDE THE SYRINGE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL TIP 1ML HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A HAIR WAS WITHIN THE SYRINGE ATTACHED TO THE BASE OF THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233286 SYRINGE 50ML LL TIP 1ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1112977 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1