BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN

    MDR report key: 11298239 · Received February 8, 2021

    Report

    Report Number
    1920898-2021-00164
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 18, 2021
    Report Date
    January 28, 2021
    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: CUSTOMER RETURNED (18) LOOSE 1CC, 8MM SYRINGES. CUSTOMER STATES THAT THE PLUNGER AND RUBBER STOPPER SEPARATED. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED THE STOPPER SEPARATED FROM THE PLUNGER ROD. SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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: ON (B)(6) 2021 , HOLDREGE RECEIVED PHOTO OF A COMPLAINT FOR STOPPER SEPARATE FROM BATCH 0140395 AND MATERIAL 328820. A VISUAL EVALUATION OF THE PHOTOS WAS PERFORMED FINDING A SYRINGE WITH THE STOPPER SEATED IN THE BARREL AND THE PLUNGER OUTSIDE OF THE BARREL. 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. DHR, L2L DISPATCHES, LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT COULD BE FOUND. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN PLUNGER AND STOPPER SEPARATED. THIS OCCURRED ON 48 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER AND RUBBER STOPPER SEPARATION. DISCOVERED WHILE PREPARING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189289 SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN SYRINGE FMF BD MEDICAL - DIABETES CARE 0140395

    Patients

    Seq Age Sex Outcome Treatment
    1