BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE 0.3ML, 31G X 8MM

    MDR report key: 7011863 · Received November 8, 2017

    Report

    Report Number
    1920898-2017-00314
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 18, 2017
    Report Date
    January 12, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903294183
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ON (B)(6) 2017, HOLDREGE RECEIVED TWENTY-SIX (26) 0.3ML, 8MM, 31G SYRINGES (6 LOOSE, 20 IN SEALED POLY BAGS) WITH THE SHELF CARTON FROM BATCH# 6242643. ALL SAMPLE WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, IT WAS NOTED THAT 21 OF 26 SAMPLES RECEIVED EXHIBITED DEFORMED/DAMAGED STOPPERS AS VISUALIZED WITHIN THE ASSEMBLED SYRINGE. UPON DISASSEMBLY OF 10 SELECTED SAMPLES, IT WAS NOTED THAT ALL STOPPER RETAINED THE DEFORMED/DAMAGED CONFIGURATION ONCE FREE FROM THE BARREL. PROBABLE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. CONCLUSION: CAPA (B)(4) WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS DEFORMED/DAMAGED STOPPERS AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 6242643 WAS MANUFACTURED PRIOR TO THE INITIATION OF THIS CAPA. NO ADDITIONAL ACTIONS AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: CUSTOMER RETURNED (26) 3/10CC, 8MM, 31G SYRINGES (6 LOOSE, 20 IN SEALED POLY BAGS) WITH THE SHELF CARTON FROM LOT # 6242643. CUSTOMER STATES THAT THE PLUNGER IS STIFF AND HARD TO MOVE. ALL RETURNED SYRINGES WERE EXAMINED AND 3 OUT OF 6 LOOSE SAMPLES AS WELL AS 18 OUT OF 20 SAMPLES FROM THE SEALED POLY BAGS EXHIBITED A DEFORMED STOPPER IN THE BARREL. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. SAMPLES WILL BE FORWARDED TO MANUFACTURING ((B)(4)) ON 15DEC2017 FOR FURTHER REVIEW. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6242643. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) DEFECTS OR NOTIFICATIONS NOTED FOR THE PRODUCTION OF THIS BATCH. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE (DEFORMED STOPPER). POSSIBLE ROOT CAUSES FOR A DAMAGED STOPPER INCLUDE: THIS CONDITION IS REFERRED TO AS A ROLLED STOPPER WHICH CAN OCCUR DURING THE ASSEMBLY PROCESS, WHEN THE PLUNGER ROD IS BEING ASSEMBLED IN THE BARREL AND THERE IS INADEQUATE (NOT ENOUGH) LUBE PRESENT IN THE BARREL ID (INNER DIAMETER) AND OR THE STOPPER ITSELF DOES NOT HAVE ENOUGH LUBE ON IT. AS A RESULT, THE STOPPER DOES NOT MOVE FREELY IN THE BARREL AND CAN BECOME STUCK AND DEFORMED. THERE IS ALSO THE POSSIBILITY THAT THE STOPPER STARTS OUT BEING MISALIGNED ON THE END OF THE PLUNGER ROD AND THEN GETS ROLLED AS IT IS BEING INSERTED INSIDE THE BARREL. ROLLED STOPPERS CAN ALSO BE CAUSED BY PARTIALLY PEELING OFF THE STOPPER BEFORE INSERTION INTO THE SYRINGE BARREL. AS PER SUPPLIER, IMPROPER STACKING OF RUBBER SHEETS IN AUTOCLAVE CART, CAUSING PINCHING/DEFORMITY. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ON A BD INSULIN SYRINGE 0.3ML, 31G X 8MM WAS STIFF AND DIFFICULT TO MOVE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791574 BD INSULIN SYRINGE 0.3ML, 31G X 8MM INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6242643 00382903294183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other