BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 8436588 · Received March 20, 2019

    Report

    Report Number
    1920898-2019-00272
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    March 3, 2019
    Report Date
    March 5, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8211738, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2018-07-30. MEDICAL DEVICE LOT #: 8239952, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2018-08-27. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A SYRINGE AND SHELF CARTONS FROM LOT # 8211738 AND LOT # 8239952. CUSTOMER STATES THAT THE PLUNGER HEAD IS BENT. THE PHOTOS WERE EXAMINED AND EXHIBITED A SLIGHTLY DEFORMED STOPPER IN THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8239952. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR DRY BARRELS. INVESTIGATION CONCLUSION: 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: 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. RATIONALE: CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE THAT THE CONSUMER ENCOUNTERED BENT PLUNGER HEADS IN SEVERAL INSULIN SYRINGES. VERBATIM: MY CAT HAS FELINE #DIABETES AND REQUIRES 1 UNIT OF #INSULIN EVERY 12 HOURS. I PURCHASE "BRAND NAME" SYRINGES FROM THE DRUG STORE BUT I'VE HAD SEVERAL DOZEN @BDANDCO VEO INSULIN SYRINGES WITH BENT PLUNGER HEADS. HOW AM I SUPPOSE TO DOES 1 UNIT (FIRST LINE) ACCURATELY WITH THIS??? ADDED FROM (B)(6) ON 03/06/2019. LOT: 8211738, EXPIRATION DATE: 2023-08-31, LOT: 8239952, EXPIRATION DATE: 2023-09-30. MY CAT HAS FELINE #DIABETES AND REQUIRES 1 UNIT OF #INSULIN EVERY 12 HOURS. I PURCHASE 'BRAND NAME" SYRINGES FROM THE DRUG STORE BUT I'VE HAD SEVERAL DOZEN @BDANDCO VEO INSULIN SYRINGES WITH BENT PLUNGER HEADS. HOW AM I SUPPOSE TO DOES 1 UNIT (FIRST LINE) ACCURATELY WITH THIS??? THESE ARE THE 2 BOXES THAT BOTH HAD A LOT OF BENT PLUNGERS. ANYTHING OVER 1 UNIT OF #INSULIN EXACTLY AND MY CAT'S NUMBERS GO BELOW 100 WHICH REQUIRES IMMEDIATE ATTENTION. PLEASE CHECK YOUR INSULIN SYRINGES IF YOU'RE USING @BDANDCO VEO INSULIN SYRINGES IN THESE BATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228413 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other