BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE INSULIN 0.5ML 31GA 8MM W30 SELF

    MDR report key: 10551554 · Received September 17, 2020

    Report

    Report Number
    9614033-2020-00125
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 14, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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: LEVEL B INVESTIGATION COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE HUB SEPARATES AND NEEDLE MISSING ON LOT # 0013095. A REVIEW OF RISK MANAGEMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, NEEDLE HUB SEPARATES, NEEDLE MISSING) WAS CAPTURED AND ADDRESSED INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 1/2CC SYRINGE WITH PACKAGING FROM LOT # 0013095. CUSTOMER STATES THAT A PIECE CAME OUT WITHOUT A NEEDLE. THE PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0013095. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THIS COMPLAINT. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD 1821700, ON 15SEP2020, HOLDREGE RECEIVED PHOTO COMPLAINT OF MATERIAL #326781 AND LOT #0013095. A VISUAL EVALUATION OF PHOTO FOUND (1) SYRINGE WITH NO NEEDLE ASSEMBLIES ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, OR ANYWHERE ON THE SYRINGE. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE CORE PIN. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.5 ML, 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. CAPA #: PR #(B)(4). RATIONALE: CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE INSULIN 0.5 ML 31 GA 8 MM W30 SELF HUB SEPARATED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HEREBY WISH TO INFORM YOU THAT WHEN PURCHASING YOUR PRODUCT, AND WHEN USING A BD ULTRA-FINE TM INSULIN SYRINGE, A PIECE CAME OUT WITHOUT A NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016089 SYRINGE INSULIN 0.5ML 31GA 8MM W30 SELF SYRINGE FMF BECTON DICKINSON DE MEXICO 0013095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other