BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 10290324 · Received July 17, 2020

    Report

    Report Number
    1920898-2020-00875
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    June 30, 2020
    Report Date
    June 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 3/10CC SYRINGES. CUSTOMER STATES THAT THE HUB AND PLUNGER CAP SEPARATES. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATES ON BOTH SAMPLES SHOWN AND ONE SAMPLE WAS SHOWN WITHOUT THE PLUNGER CAP. 2 SAMPLES WERE RETURNED. BDJ CONFIRMED THAT THE NEEDLE SHIELD WITH HUB WAS DETACHED FROM THE BARREL AND ONE PLUNGER CAP WAS MISSING. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231316. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 6TH RELATED COMPLAINT FOR NEEDLE HUB SEPARATES AND THE 1ST RELATED COMPLAINT FOR PLUNGER CAP SEPARATES ON LOT # 9231316. A REVIEW OF RISK MANAGEMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, NEEDLE HUB SEPARATES AND PLUNGER CAP SEPARATES) WAS CAPTURED AND ADDRESSED APPROPRIATELY. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: A VISUAL EVALUATION OF PHOTO FOUND (2) SYRINGES WITH NO NEEDLE ASSEMBLIES ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARRELS, OR ANYWHERE ON THE SYRINGES. THERE DID NOT APPEAR TO BE ANY CORE PIN DAMAGE. (1) OF THE SYRINGES WAS ALSO MISSING A PLUNGER CAP. HUB SEPARATES AND PLUNGER CAP SEPARATES: PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 3/10CC, 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. DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. RATIONALE: CAPA# (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 NEEDLE HUBS SEPARATED FROM THEIR RESPECTIVE BD ULTRA-FINE¿ INSULIN SYRINGES BEFORE USE. ADDITIONALLY, IT WAS REPORTED THAT THE PLUNGER CAP SEPARATED FROM 1 SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CUSTOMER REPORTED TWO ISSUES: ONE IS HUB SEPARATION (X2) AND THE OTHER IS PLUNGER CAP SEPARATION (X1)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756763 BD ULTRA-FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other