BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 11102210 · Received December 31, 2020

    Report

    Report Number
    1911916-2020-01155
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    December 3, 2020
    Report Date
    January 22, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830 AND LOT NUMBER 0191268. THE REVIEW DID NOT REVEAL, ANY DETECTED QUALITY ISSUES, DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE CAME IN AN OPENED PACKAGING BLISTER, WITH THE RUBBER STOPPER AND PLUNGER ROD ALL THE WAY DOWN. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN TESTED, FOR SUSTAINING FORCE. AND ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. ONE PHOTO WAS PROVIDED, IT SHOWS A SYRINGE WITH NO PACKAGING BLISTER AND THE RUBBER STOPPER-PLUNGER ROD ALL THE WAY DOWN. NO DEFECTS OR IMPERFECTIONS ARE OBSERVED. BASED ON THE INVESTIGATION RESULTS, THE SAMPLE RECEIVED DID NOT SHOW THE SYMPTOM REPORTED BY THE CUSTOMER. AND AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT SYRINGE 20ML LL S/C 48 PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE IS STIFF. SHE SAY, THAT IT IS TOO STIFF TO USE WHEN PULLING.

    Additional Manufacturer Narrative · 1

    (B)(4).. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830 AND LOT NUMBER 0191268. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE CAME IN AN OPENED PACKAGING BLISTER WITH THE RUBBER STOPPER AND PLUNGER ROD ALL THE WAY DOWN. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN TESTED FOR SUSTAINING FORCE AND ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. ONE PHOTO WAS PROVIDED. IT SHOWS A SYRINGE WITH NO PACKAGING BLISTER AND THE RUBBER STOPPER-PLUNGER ROD ALL THE WAY DOWN. NO DEFECTS OR IMPERFECTIONS ARE OBSERVED. INVESTIGATION CONCLUSION: 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: BASED ON THE INVESTIGATION RESULTS, THE SAMPLE RECEIVED DID NOT SHOW THE SYMPTOM REPORTED BY THE CUSTOMER AND AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. RATIONALE: THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 20ML LL S/C 48 PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE IS STIFF. SHE SAY THAT IT IS TOO STIFF TO USE WHEN PULLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564258 SYRINGE 20ML LL S/C 48 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0191268 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1