BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN

    MDR report key: 10565041 · Received September 22, 2020

    Report

    Report Number
    1920898-2020-01275
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 13, 2020
    Report Date
    September 14, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT FOR BARREL DAMAGED/CRACKED ON LOT # 9151501. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 14 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, BARREL DAMAGED/CRACKED) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A 1/2CC SYRINGE. CUSTOMER STATES THAT THE BARREL IS CRACKED. THE PHOTO WAS EXAMINED AND EXHIBITED A CRACK IN THE BARREL RANGING FROM ABOUT THE 5-20 UNIT MARKINGS. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9151501. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200819854] NOTED THAT DID NOT PERTAIN TO THE 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 (B)(4). ON 17SEP2020, HOLDREGE RECEIVED A COMPLAINT, VIA A PICTURE, FROM MATERIAL 328821, BATCH 9151501. VISUAL INSPECTION OF THE PICTURE FOUND THE BARREL CRACKED FROM 5 TILL THE 20 UNIT MARKING. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.5ML, 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 #65242 WAS OPENED FOR DAMAGED BARRELS AT THE PRINTERS. THE TIMING OF THE DIAL WAS OFF. CORRECTIVE ACTION: ADJUSTED THE TIMING OF THE DIAL. 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 SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN BARREL WAS CRACKED, AND UNABLE TO DRAW INSULIN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACKED BARREL. A FATHER OF T1DM PATIENT DISCOVERED CRACKED SYRINGE BARREL. HE WAS NOT ABLE TO WITHDRAW INSULIN BECAUSE OF THE CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035575 SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN SYRINGE FMF BD MEDICAL - DIABETES CARE 9151501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other