BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9965124 · Received April 15, 2020

    Report

    Report Number
    1920898-2020-00380
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Date of Event
    March 31, 2020
    Report Date
    May 14, 2020
    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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CUSTOMER RETURNED FIVE (5) LOOSE 31GX6MM, 0.3ML BD INSULIN SYRINGES. CONSUMER REPORTED THE NEEDLE SHIELDS ARE DIFFICULT TO REMOVE AND SOME OF THE NEEDLES HAVE BEEN PULLED OUT OF THE NEEDLE HUB AS A RESULT. ALL FIVE RETURNED SYRINGES WERE EXAMINED AND IT WAS OBSERVED THAT THREE OF THE SYRINGES EXHIBITED THE NEEDLE HUB/SHIELD ASSEMBLY SEPARATED FROM THE SYRINGE BARREL; NO DAMAGE TO THE BARREL TIPS WAS OBSERVED. THE TWO SYRINGES THAT DID NOT EXHIBIT NEEDLE HUB SEPARATION WERE TESTED TO DETERMINE THE SHIELD REMOVAL FORCE (SPECS: SHIELD REMOVAL FORCE FOR 0.3 ML SYRINGE AFTER STERILIZATION IS 0.85 TO 5.95LBS) AND THE FOLLOWING WAS OBSERVED: SAMPLE NUMBER: SHIELD REMOVAL FORCE (LBS): SAMPLE 1, 3.45. SAMPLE 2, 2.82. THE TWO TESTED SYRINGES TESTED WITHIN SPECIFICATION; NO CANNULA SEPARATION AND NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THESE TWO SAMPLES. SAMPLE WILL BE FORWARDED TO MANUFACTURING (HOLDREGE) ON 6MAY2020 FOR FURTHER REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200845676, 200845565] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [200845567, 200845495] NOTED FOR HIGH SHIELD PULL. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES). ROOT CAUSE DESCRIPTION: "A VISUAL EVALUATION OF PHOTO FOUND (3) SYRINGE WITH NO NEEDLE ASSEMBLIES ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARRELS, OR ANYWHERE ON THE SYRINGE. THERE DID NOT APPEAR TO BE ANY CORE PIN DAMAGE. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.3ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. "TIP-2019-37 WAS IMPLEMENTED ON 10JUL2019 FOR INCREASED SAMPLING FOR NEEDLE HUB SEPARATES IN 0.3ML. CAPA1122103 HAS BEEN OPENED TO ADDRESS THIS ISSUE. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEPARATION OCCURRED DURING USE WITH A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PET OWNER REPORTED DIFFICULTY REMOVING NEEDLE SHIELD ON HER CAT'S INSULIN SYRINGES. STATED SOME OF THE NEEDLE SHIELDS SHE HAS TO YANK SO HARD TO GET OFF THAT IT PULLS THE NEEDLE OUT OF THE NEEDLE HUB. STATED SOME OF THE NEEDLE SHIELDS SHE CAN'T REMOVE AT ALL. STATED THIS HAPPENED SOMETIME OVER THE WEEKEND, EXACT DATE UNKNOWN."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200845676, 200845565] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [200845567, 200845495] NOTED FOR HIGH SHIELD PULL. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEPARATION OCCURRED DURING USE WITH A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PET OWNER REPORTED DIFFICULTY REMOVING NEEDLE SHIELD ON HER CAT'S INSULIN SYRINGES. STATED SOME OF THE NEEDLE SHIELDS SHE HAS TO YANK SO HARD TO GET OFF THAT IT PULLS THE NEEDLE OUT OF THE NEEDLE HUB. STATED SOME OF THE NEEDLE SHIELDS SHE CAN'T REMOVE AT ALL. STATED THIS HAPPENED SOMETIME OVER THE WEEKEND, EXACT DATE UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429632 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 9252570 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other