BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD QS SYRINGE LS

    MDR report key: 14982551 · Received July 11, 2022

    Report

    Report Number
    2243072-2022-00935
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    May 30, 2022
    Report Date
    June 29, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2021096. 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 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. BASED SOLELY ON THE DESCRIPTION OF THE EVEN, OUR ENGINEERS SPECULATE THAT THE ROOT CAUSE MAY BE ASSOCIATED WITH EXCESS SILICONE BEING PRESENT IN THE BODY OF THE SYRINGE. TO PREVENT THIS ISSUE FROM CONTRIBUTING TO FUTURE OCCURRENCES OUR ENGINEERS HAVE NOTIFIED AND RETRAINED THE APPROPRIATE PERSONNEL, AS WELL AS INCREASING THE REQUIREMENTS FOR IN-PROCESS INSPECTION & TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD QS SYRINGE LS EXPERIENCED BUBBLES DURING THE PREPARATION OF MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE REPORTS THE PRESENCE OF RECALCITRANT BUBBLES DURING THE PREPARATION OF MEDICATION. IN THE CONTEXT OF IMMUNO-ALLERGY TESTING, XYLOCAINE AS A LOCAL ANAESTHETIC IS PREPARED IN THESE SYRINGES. AS THE PREPARATION VOLUMES ARE VERY SMALL, THE PRESENCE OF BUBBLES IS NOT NEGLIGIBLE (SOURCE OF ERROR, NOT RELIABLE). THE ALTERNATIVE IS TO TAP THE SYRINGES TO MAKE THE BUBBLES DISAPPEAR AS BEST AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913376 BD QS SYRINGE LS PISTON SYRINGE FMF BECTON DICKINSON 2021096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown