BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 30GA 8MM 10BAG 500CAS AP

    MDR report key: 9986052 · Received April 22, 2020

    Report

    Report Number
    1920898-2020-00407
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    April 9, 2020
    Report Date
    April 13, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL A 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 MISSING LABEL CONTENT (NO LOT) LOT # 9231286. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF SHELF CARTONS OF 1/2CC, 8MM, 30G SYRINGES FROM LOT # 9231286. CUSTOMER STATES THAT THERE IS NO LOT. THE PHOTOS WERE EXAMINED AND EXHIBITED NO LOT NUMBER, MANUFACTURING DATE, OR EXPIRATION DATE INFORMATION PRINTED ON THE BARREL. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231286. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200846531] 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 1530840, ON (B)(6) 2020, HOLDREGE RECEIVED A COMPLAINT, VIA PICTURES, FROM MATERIAL 328868, BATCH 9231286. ONE OF THE PICTURES SHOWED 1 CARTON THAT WERE MISSING THE LOT CODING. PROCESS SUMMARY: THE EQUIPMENT ERECTS CARTONS AND AN ASSOCIATE PLACES THE APPROPRIATE NUMBER OF BAGS INTO THE CARTON. THE CARTONS ARE THEN CLOSED AND PLACED ON THE OUTFEED CONVEYOR. THE LOT CODING IS LASER ETCHED ONTO THE CARTON THE TRANSFERRED TO THE CASEPACK WHERE 5 CARTONS ARE PUSHED INTO A WRAPAROUND CASE. THIS CASE IS THEN GLUED AND CONTINUES ON TO BE LABELLED AND PALLETIZED. THERE WERE NO QUALITY NOTIFICATIONS OR LOG BOOK ENTRIES DURING THE PRODUCTION OF THIS BATCH THAT PERTAINED TO THIS DEFECT. A ROOT CAUSE CANNOT BE DETERMINED. 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 30GA 8MM 10BAG 500CAS AP WAS MISSING LABEL INFORMATION. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452403 SYRINGE 0.5ML 30GA 8MM 10BAG 500CAS AP SYRINGE FMF BD MEDICAL - DIABETES CARE 9231286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other