BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 10155986 · Received June 15, 2020

    Report

    Report Number
    1920898-2020-00669
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    May 27, 2020
    Report Date
    May 29, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 1/2CC, 8MM, 31G SYRINGES WITH THE SHELF CARTON FROM LOT # 9140639. CUSTOMER STATES THAT WHEN PULLING THE COVER THE NEEDLE GETS OUT TOGETHER WITH IT. THE PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9140639. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200826647] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 9140639. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, NEEDLE HUB SEPARATES) WAS CAPTURED AND ADDRESSED APPROPRIATELY. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: ON 05JUN2020, (B)(4) RECEIVED PHOTO COMPLAINT. A VISUAL EVALUATION OF PHOTO FOUND (7) SYRINGE, (2) SYRINGES WITH NO NEEDLE ASSEMBLY ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, OR ANYWHERE ON THE SYRINGE. THE REST OF THE 5 SYRINGES WERE PERFECTLY FINE. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 1/2CC, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. ROOT CAUSE: L2L DISPATCH #68605 WAS CREATED FOR AIR JET OUT OF ADJUSTMENT. CORRECTIVE ACTION: ADJUSTED THE AIR JET. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUB SEPARATED FROM THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE DURING USE. THIS OCCURRED ON 7 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN PULLING THE COVER THE NEEDLE GETS OUT TOGETHER WITH IT, MAKING IMPOSSIBLE TO USE THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619962 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9140639

    Patients

    Seq Age Sex Outcome Treatment
    1 Other