BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 6MM 10BAG 500CS

    MDR report key: 9584519 · Received January 13, 2020

    Report

    Report Number
    1920898-2019-01541
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 27, 2019
    Report Date
    January 23, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249121
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 2ND RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE PLUNGER ROD FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE HENCE THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1.0ML 31GA 6MM 10BAG 500CS EXPERIENCED DIFFICULT PLUNGER ROD MOVEMENT, AND WERE UNABLE TO INJECT INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324912, BATCH NO. 9140733. VERBATIM: PHARMACIST CALLED ON BEHALF OF CONSUMER STATED, AFTER CONSUMER DRAWS UP INSULIN, SHE CANNOT GET THE PLUNGER ROD TO MOVE PLUNGER ROD IS DIFFICULT TO MOVE AND CONSUMER IS WASTING INSULIN CONSUMER WAS NOT ABLE TO DISPENSE THE INSULIN AS A RESULT. PHARMACIST STATED, SHE WAS ABLE TO DUPLICATE ISSUE BY TRYING IT HERSELF ON A COUPLE OF SYRINGES FROM THE BOX THE CONSUMER IS USING. 4 SYRINGES AFFECTED, PULLED TWO SYRINGES FROM 2 DIFFERENT BAGS AND HAD THE SAME AFFECT PHARMACIST REPLACED THE BOX AND IS LOOKING FOR THE STORE TO BE COMPENSATED. SAMPLES AVAILABLE LOT: 9140733, ITEM: 324912 AND INCIDENT DATE: (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1.0ML 31GA 6MM 10 BAG 500CS EXPERIENCED DIFFICULT PLUNGER ROD MOVEMENT, AND WERE UNABLE TO INJECT INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324912, BATCH NO. 9140733. VERBATIM: PHARMACIST CALLED ON BEHALF OF CONSUMER STATED, AFTER CONSUMER DRAWS UP INSULIN, SHE CANNOT GET THE PLUNGER ROD TO MOVE PLUNGER ROD IS DIFFICULT TO MOVE AND CONSUMER IS WASTING INSULIN CONSUMER WAS NOT ABLE TO DISPENSE THE INSULIN AS A RESULT. PHARMACIST STATED, SHE WAS ABLE TO DUPLICATE ISSUE BY TRYING IT HERSELF ON A COUPLE OF SYRINGES FROM THE BOX THE CONSUMER IS USING. 4 SYRINGES AFFECTED, PULLED TWO SYRINGES FROM 2 DIFFERENT BAGS AND HAD THE SAME AFFECT PHARMACIST REPLACED THE BOX AND IS LOOKING FOR THE STORE TO BE COMPENSATED. SAMPLES AVAILABLE. LOT: 9140733, ITEM: 324912, INCIDENT DATE: (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47304 SYRINGE 1.0ML 31GA 6MM 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324912 9140733 00382903249121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other