BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 9162275 · Received October 7, 2019

    Report

    Report Number
    1213809-2019-01008
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 19, 2019
    Report Date
    December 3, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO AND TWENTY 3ML SYRINGES IN FULLY SEALED BLISTER PACKS CONFIRMED TO BE FROM BATCH 9171885 (P/N 309657) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A VARYING DEGREE OF MISSING PRINT ON THE SYRINGES. IT APPEARED THE SYRINGE WITH THE MOST PRINT WAS MISSING ABOVE 2 1/2ML MARKING AND THE REST WERE PROGRESSIVE WORSE TO THE UNTIL THERE WAS NO PRINT ON THE BARRELS. MACHINE LOGS INDICATE THERE WAS ISSUES WITH THE PRINT MANIFOLD DURING THE MANUFACTURE OF THIS BATCH. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH AN EQUIPMENT FAILURE. THIS WAS LIKELY CAUSED BY A MALFUNCTION OF THE SENSOR THAT REGULATES THE INK FLOW. THE MISSING PRINT DEFECT WAS DETECTED DURING THE MANUFACTURE OF A SUBASSEMBLY BATCH AND A REQUALIFICATION WAS PERFORMED. IT IS POSSIBLE SOME SYRINGES WERE ABLE TO ESCAPE DETECTION. ADJUSTMENTS WERE MADE TO THE SENSOR AND THE MANIFOLD WAS CLEANED (B)(6) 2019. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 3ML LL 200 S/C HAS BEEN FOUND EXPERIENCING 40 OCCURRENCES OF SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGES HAD DEFECTIVE SCALE MARKINGS. PER PIR: DEFECTIVE MARKINGS IDENTIFIED AND PRODUCT BEING PULLED EMAIL: HELLO BD TEAM, IT WAS JUST BROUGHT TO OUR ATTENTION THAT SOME OF THE 3ML SYRINGES HAVE DEFECTIVE MARKINGS. OUR QUALITY RN IS IN THE PROCESS OF WORKING WITH THE STORE ROOM TO PULL THEM. THE BD REFERENCE # IS (B)(4) AND THE LOT# IS 9171885 (EXP 05-31- 2024).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE 3ML LL 200 S/C HAS BEEN FOUND EXPERIENCING 40 OCCURRENCES OF SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGES HAD DEFECTIVE SCALE MARKINGS. PER PIR: DEFECTIVE MARKINGS IDENTIFIED AND PRODUCT BEING PULLED. EMAIL: HELLO BD TEAM, IT WAS JUST BROUGHT TO OUR ATTENTION THAT SOME OF THE 3ML SYRINGES HAVE DEFECTIVE MARKINGS. OUR QUALITY RN IS IN THE PROCESS OF WORKING WITH THE STORE ROOM TO PULL THEM. THE BD REFERENCE # IS 309657 AND THE LOT# IS 9171885 (EXP 05-31-2024).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958682 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9171885 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other