BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC PACK¿ BD LORD'S¿ INSULIN SYRINGE WITH NEEDLE

    MDR report key: 7290959 · Received February 22, 2018

    Report

    Report Number
    1920898-2018-00088
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    February 2, 2018
    Report Date
    March 27, 2018
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED FIVE LOOSE 3/10CC, 8MM SYRINGES. CUSTOMER STATES THAT THE INSIDE OF THE BARREL WAS BLACKENED AND THE PLUNGERS WERE DEFORMED. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A DEFORMED STOPPER IN THE BARREL. ALL REMAINING SAMPLES EXHIBITED SMEARED INK ON THE OUTER SURFACE OF THE BARREL. (B)(4) RECEIVED FIFTY LOOSE 0.3ML, 8MM SYRINGES FROM REPORTED BATCH# 6221856. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE (B)(4), SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #6221856. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SMUDGED INK ON SURFACE OF BARREL AND DEFORMED STOPPER). POSSIBLE ROOT CAUSE FOR THE SMUDGED INK ON THE BARREL IS ATTRIBUTED TO PAD SWELLING ON THE MANDRIL DURING THE PRINTING PROCESS. AS THE PADS ARE USED, THEY GRADUALLY SWELL AND CAN CAUSE THIS TYPE OF "SMEAR" OR "SMUDGE AFFECT. A PROBLEM SOLVING TEAM HAS BEEN TASKED WITH IMPROVING PRINT QUALITY ON ALL PRODUCTION LINES WITHIN THE PLANT. THE TEAM IS SYSTEMATICALLY ASSESSING AND ADDRESSING EACH PRINTER INDIVIDUALLY FOR IMPROVEMENTS. CAPA (B)(4) WAS INITIATED TO ADDRESS SUCH ISSUES AT THIS TIME. 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

    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 BD PLASTIC PACK¿ BD LORD'S¿ INSULIN SYRINGE WITH NEEDLE WAS DISCOLORED BLACK AND THE PLUNGER WAS MALFORMED. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131613 BD PLASTIC PACK¿ BD LORD'S¿ INSULIN SYRINGE WITH NEEDLE INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 6221856

    Patients

    Seq Age Sex Outcome Treatment
    1 Other