BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG

    MDR report key: 12170042 · Received July 14, 2021

    Report

    Report Number
    1920898-2021-00757
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 15, 2021
    Report Date
    July 6, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    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. INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 3/01CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0167709. CUSTOMER STATES THAT THE AIR BUBBLES REMAINED IN THE BARREL OF THE SYRINGE EVEN WHEN SHE PUSHED THE PLUNGER TO REMOVE THE AIR BUBBLES. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A DEFORMED STOPPER IN THE BARREL, WHICH COULD PREVENT AIR FROM BEING REMOVED FROM THE BARREL WHEN PREPARING FOR AN INJECTION. ALL REMAINING SYRINGES WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0167709 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SEVEN (7) NOTIFICATIONS [200895854, 200896056, 200896025, 200895892, 200895293, 200894747, 200894674] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. DEVICE HISTORY RECORD; L2L AND LOGBOOK EVALUATION: THE DEVICE HISTORY (DHR) FOR BATCH 0167709 WAS REVIEWED. THE SYRINGES WERE ASSEMBLED FROM 24JUL2020 TO 30JUL2020. DURING THE MANUFACTURING PROCESS, THE FOLLOWING INSPECTIONS ARE COMPLETED ON REGULAR INTERVALS: VISUAL INSPECTION (WITHOUT AID) EVERY 2 HOURS: EXCESSIVE BARREL LUBRICANT AS EVIDENCED BY ¿POOLING¿ OR FORMATION OF DROPLETS . VISUAL INSPECTION EVERY 2 HOUR: BARREL LUBRICANT SHALL BE ON THE INSIDE SURFACES OF THE SYRINGE ONLY. FUNCTIONAL INSPECTION EVERY 4 HOURS: BREAKOUT & SUSTAINING TO ENSURE ADEQUATE PLUNGER MOVEMENT. IF A DEFECT IS FOUND DURING AN INSPECTION A QUALITY NOTIFICATION IS INITIATED. QUALITY NOTIFICATIONS #200895892 WAS WRITTEN ON 27JUL2020 FOR ISSUES RELATING TO THE ASSEMBLED SYRINGE DEFECT. MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND DISPATCH #102382 WAS CREATED ON 27JUL020 FOR DRY BARRELS. 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 (DEFORMED STOPPER). 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: INSUFFICIENT BARREL LUBE. A DRY BARREL IS THE RESULT OF THE LACK OF SILICONE IN THE BARREL WHICH ALLOWS THE PLUNGER / STOPPER TO MOVE WITH LIMITED EASE. FOUND SEVERAL LINES FROM THE IVEK PUMPS WERE DAMAGED AND CRIMPED. 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 0.3ML 31GA 6MM HALF UNIT 10BAG STOPPER WAS DEFORMED. THIS OCCURRED ON 10 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED THAT SHE CAN'T REMOVE AIR BUBBLES OF INSULIN IN THE SYRINGE DURING THE SAFETY CHECK BEFORE INJECTION AND THE AIR BUBBLES REMAINED IN THE BARREL OF THE SYRINGE EVEN WHEN SHE PUSHED THE PLUNGER TO REMOVE THE AIR BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063022 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 0167709 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1