BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL CLEAR 14GA 1-1/4IN

    MDR report key: 11341465 · Received February 18, 2021

    Report

    Report Number
    3003152976-2021-00091
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 22, 2021
    Report Date
    March 12, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SEVEN USED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED IN ALL RECEIVED SAMPLES. THE PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, IN SIX OF THE SAMPLES IT WAS CONFIRMED THERE WAS NO DAMAGE IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED A LEAK. ONE SYRINGE WAS OBSERVED TO HAVE DAMAGE ON THE BARREL, A DENT WAS NOTED NEAR THE 50ML MARKING. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1912211, AN INCIDENT WAS DETECTED RELATED TO THE IMBALANCE OF THE BALL BEARINGS IN THE ASSEMBLY STATION WHICH RESULTED IN BARRELS JAMMING WITHIN THE MACHINE. ONCE IDENTIFIED, OUR MECHANICAL TEAM REPAIRED THIS ISSUE AND DEFECTIVE UNITS WERE SCRAPPED. IT IS LIKELY THIS IMPACTED UNIT WAS NOT PROPERLY DETECTED. THERE WAS NO NON-CONFORMANCES IDENTIFIED DURING MANUFACTURING THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT OF MEDICATION REMAINING IN THE SYRINGE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, INCLUDING TIGHTNESS TESTING TO VERIFY THE STOPPER SEAL AND SILICONE CONTENT AND FORCE TESTING TO VERIFY PROPER PLUNGER MOVEMENT. FIVE RETAINED SAMPLES OF LOT 1912211 WERE USED TO CONDUCT THESE TESTS, IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND WAS VERIFIED TO BE WITHIN REQUIRED SPECIFICATIONS. BASED ON OUR INVESTIGATION AND SAMPLE EVALUATION, WE CANNOT IDENTIFY A DEFECTIVE ROOT CAUSE AT THIS TIME. IN RELATION TO THE ONE DAMAGED SYRINGE, THE LEAK WAS LIKELY A RESULT OF THE DENT OBSERVED ON THE SYRINGE BARREL WHICH OCCURRED DURING MANUFACTURING. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL CLEAR 14GA 1-1/4IN LEAKED AND SYRINGE PUMP ALARMS. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1) DURING THE USE, THE DRAWN LIQUID FLOWS TO THE BACK THROUGH THE STOPPER. PROCUREMENT HAS SAMPLES AVAILABLE. 2) WE NOTICE THAT RESTS REMAIN IN THE PERFURSOR SYRINGES WHEN PLACING THEM IN THE SPACE-PERFUSOREN AND SELECTING THE RIGHT SOFTWARE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL CLEAR 14GA 1-1/4IN LEAKED AND SYRINGE PUMP ALARMS. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE USE, THE DRAWN LIQUID FLOWS TO THE BACK THROUGH THE STOPPER. PROCUREMENT HAS SAMPLES AVAILABLE. WE NOTICE THAT RESTS REMAIN IN THE PERFURSOR SYRINGES WHEN PLACING THEM IN THE SPACE-PERFUSOREN AND SELECTING THE RIGHT SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239587 SYRINGE 50ML LL CLEAR 14GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1912211

    Patients

    Seq Age Sex Outcome Treatment
    1