BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 9696074 · Received February 11, 2020

    Report

    Report Number
    1920898-2020-00114
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 19, 2020
    Report Date
    March 26, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 20 FEBRUARY 2020 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# 9161986. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200829078, 200828969] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (B)(4) LOOSE 3/10C, 8MM SYRINGES. CUSTOMER STATES THAT THE STOPPER WAS SEPARATED FROM THE PLUNGER RODS. ALL RETURNED SYRINGES WERE EXAMINED AND 13 OUT OF 27 SAMPLES EXHIBITED A DEFORMED STOPPER IN THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9161986. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200829078, 200828969] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 3/10CC, 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. ROOT CAUSE: AIR IN THE SILICONE LINES. CORRECTION: GUN #4 ON JZ METRO WAS PURGED TO REMOVE THE AIR FROM THE LINE PER L2L DISPATCH #69785.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE STOPPER SEPARATED FROM THE PLUNGER ROD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328438; BATCH NO. 9161986. IT WAS REPORTED THAT STOPPER WAS SEPARATED FROM PLUNGER RODS. VERBATIM: CONSUMER REPORTED RUBBER STOPPER SEPARATED FROM PLUNGER ROD BEFORE INJECTION, STATED THAT SHE EXAMINED 8 PACKAGES OF 10 SYRINGES FROM THE SAME BOX AND FOUND THAT THEY ALL HAD THE SAME ISSUE, CONSUMER DID NOT USE THE SYRINGES. SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE STOPPER SEPARATED FROM THE PLUNGER ROD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328438, BATCH NO. 9161986. IT WAS REPORTED THAT STOPPER WAS SEPARATED FROM PLUNGER RODS. VERBATIM: CONSUMER REPORTED RUBBER STOPPER SEPARATED FROM PLUNGER ROD BEFORE INJECTION, STATED THAT SHE EXAMINED 8 PACKAGES OF 10 SYRINGES FROM THE SAME BOX AND FOUND THAT THEY ALL HAD THE SAME ISSUE, CONSUMER DID NOT USE THE SYRINGES. SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE STOPPER SEPARATED FROM THE PLUNGER ROD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328438 BATCH NO. 9161986. IT WAS REPORTED THAT STOPPER WAS SEPARATED FROM PLUNGER RODS. VERBATIM: CONSUMER REPORTED RUBBER STOPPER SEPARATED FROM PLUNGER ROD BEFORE INJECTION, STATED THAT SHE EXAMINED 8 PACKAGES OF 10 SYRINGES FROM THE SAME BOX AND FOUND THAT THEY ALL HAD THE SAME ISSUE, CONSUMER DID NOT USE THE SYRINGES. SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160434 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 9161986 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other