BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7818044 · Received August 27, 2018

    Report

    Report Number
    1920898-2018-00658
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 28, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908411035
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1CC 12.7MM 30G SYRINGE IN AN OPEN POLYBAG. CUSTOMER STATES THE STOPPER SEPARATED FROM THE PLUNGER BEFORE USE. THE RETURNED SYRINGE WAS EXAMINED AND IT EXHIBITED A BROKEN PLUNGER ROD TIP, WHICH CAUSED THE STOPPER TO SEPARATE FROM THE PLUNGER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7241942. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [200712761, 200712700, 200712546, 200712545] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR STOPPER SEPARATED FROM PLUNGER ON LOT # 7241942. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 31 AUGUST 2018 FOR FURTHER REVIEW. ON 11SEP2018, HOLDREGE RECEIVED ONE (1) 1ML, 12.7MM, 30G SYRINGE IN OPENED POLYBAG FROM BATCH # 7241942. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. PROBABLE ROOT CAUSE IS A JAM ON THE METRO DURING MARRIAGE OF THE STOPPER TO THE PLUNGER ROD. THE JAM WOULD HAVE NEEDED TO OCCUR PRIOR TO THE PREP DIAL, WHERE THE TWO COMPONENTS ARE MARRIED, AND GIVEN THE TYPE OF DAMAGE TO THE PLUNGER ROD TIP, IT APPEARS THE DESTRUCTIVE FORCE WAS ALSO ROTATIONAL. A NON-DEFECTIVE PLUNGER ROD WAS USED TO REMOVE THE STOPPER FROM THE BARREL AND NOTED THAT THE MISSING PORTION OF THE DEFECTIVE PLUNGER ROD WAS NOT PRESENT WITHIN THE STOPPER/SAMPLE. PROBABLE ROOT CAUSE IS LIKELY TO BE A JAM ON THE METRO, PRIOR TO ASSEMBLY OF THE STOPPER, RESULTING IN THE DAMAGED PLUNGER ROD. WHILE A STOPPER IS UNABLE TO FULLY ASSEMBLE ONTO THE DAMAGED PLUNGER ROD, THE STOPPER DOES FIT TO A DEGREE SO THAT ASSEMBLY OF THE STOPPER/PLUNGER ROD INTO A BARREL COULD BE POSSIBLE. THE RESULTING DEVICE, HOWEVER, WOULD BE INOPERABLE AS THE CONNECTION BETWEEN THE STOPPER AND PLUNGER ROD WOULD BE INSUFFICIENT AS TO FACILITATE ASPIRATION AND INJECTION. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE EXHIBITED PLUNGER STOPPER SEPARATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. 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 THE BD ULTRA-FINE¿ NEEDLE EXHIBITED PLUNGER STOPPER SEPARATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662054 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7241942 00382908411035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other