BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7562760 · Received June 1, 2018

    Report

    Report Number
    1920898-2018-00386
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 7, 2018
    Report Date
    September 5, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908431033
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6130803. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200645170, 200645236] 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 PLUNGER ROD DIFFICULT TO MOVE ON LOT # 6130803. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SAMPLES WERE RECEIVED AND EVALUATED. INVESTIGATION SUMMARY: FRANKLIN LAKES EVALUATION: CUSTOMER RETURNED (2) LOOSE 3/10CC, 12.7MM SYRINGES. CUSTOMER STATES THAT THE PLUNGERS ARE DIFFICULT TO MOVE. BOTH RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A DEFORMED STOPPER IN THE BARREL WHICH COULD CAUSE THE PLUNGER ROD TO BE DIFFICULT TO MOVE. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 13JUL2018 FOR FURTHER REVIEW. ON 18JUL2018, HOLDREGE RECEIVED TWO (2) LOOSE 0.3ML, 12.7MM SYRINGES FROM REPORTED BATCH# 6130803. ALL SAMPLES WERE 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. CYCLE TESTING WAS PERFORMED ON THE SAMPLES AND NOTED A NO ABNORMAL FINDINGS AT THAT TIME. ADDITIONALLY, THE PLUNGER ROD/STOPPER ASSEMBLY WAS DISASSEMBLED FROM THE SYRINGE BARREL AND NOTED THAT THE STOPPER RETAINED ITS DEFORMED CONFIGURATION AT THAT TIME. PROBABLE ROOT CAUSES INCLUDE, BUT ARE NOT LIMITED TO: A MISALIGNMENT DURING ASSEMBLY OF THE PLUNGER ROD/STOPPER INTO THE SYRINGE BARREL AND/OR A SUPPLIER RELATED MOLDING DEFECT. CAPA 122939 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS DEFORMED/DAMAGED STOPPERS AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 6130803 WAS MANUFACTURED PRIOR TO INITIATION OF THIS CAPA; NO ADDITIONAL ACTIONS AT THIS TIME. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DEFORMED STOPPER).

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE:YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER ON AN INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER ON AN INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ON AN INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404193 INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6130803 00382908431033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other