BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB

    MDR report key: 9745708 · Received February 24, 2020

    Report

    Report Number
    1920898-2020-00163
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    January 15, 2019
    Report Date
    March 6, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    30382903059509
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ON 4 MAR 2020, HOLDREGE RECEIVED A PHOTO COMPLAINT. A VISUAL EVALUATION OF THE PHOTOS WAS PERFORMED FINDING THE STOPPER SMEARED ON THE INSIDE OF THE BARREL. PROCESS SUMMARY: THE SYRINGE SUB-ASSEMBLY SYRINGE MACHINE, WHICH FEEDS 1ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, AND VARIOUS TRANSFER DIALS. ROOT CAUSE: STOPPER RAIL OUT OF ALIGNMENT CORRECTIVE ACTION: LOG BOOK ENTRY ON 20AUG2017 INDICATED THE AIR WAS TURNED DOWN AIR ON THE BOTTOM OF THE PLUNGER INFEED AND MOVED THE PLUNGER RAIL TO ALIGN WITH THE STOPPER RAIL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7171631. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200706617] NOTED FOR POOLING. THERE WERE FOUR (4) NOTIFICATIONS [200707701, 200708682, 200708212, 200707380] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB HAD FOREIGN MATTER ON THE INSIDE OF THE SYRINGE FOUND PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ¿IT WAS REPORTED THAT THE APPEARED THE MELTED PLASTIC WAS ON THE INSIDE OF THE SYRINGE BARREL. TECHNICAL COMPLAINT RECEIVED FROM THE MARKET. SYRINGE PRESENTED AS IT SEEMED MELTED PLASTIC ON THE INSIDE."

    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 WAS REPORTED BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB HAD FOREIGN MATTER ON THE INSIDE OF THE SYRINGE FOUND PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ¿IT WAS REPORTED THAT THE APPEARED THE MELTED PLASTIC WAS ON THE INSIDE OF THE SYRINGE BARREL. TECHNICAL COMPLAINT RECEIVED FROM THE MARKET. SYRINGE PRESENTED AS IT SEEMED MELTED PLASTIC ON THE INSIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211715 BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB PISTON SYRINGE MEG BD MEDICAL - DIABETES CARE 305950 7171631 30382903059509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other