BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU

    MDR report key: 9869679 · Received March 23, 2020

    Report

    Report Number
    1920898-2020-00295
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    March 2, 2020
    Report Date
    April 9, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. CUSTOMER RETURNED (294) 29GX12.7MM, 1ML BD INSULIN SYRINGES FROM LOT 9140524. CONSUMER REPORTED WHEN DRAWING UP SOLUTION (METHAMPHETAMINE) IT WAS DIFFICULT AND THEN HARD TO PUSH ON PLUNGER. ALL 294 RETURNED SYRINGES WERE EXAMINED AND IT WAS OBSERVED THAT 293 WERE IN SEALED/UNUSED BLISTER PACKS, AND ONE WAS IN AN OPEN/USED BLISTER PACK. THE ONE USED SYRINGE WAS EXAMINED, THEN TESTED FOR PLUNGER ROD MOVEMENT AND FLOW: THE PLUNGER ROD WAS ABLE TO MOVE PROPERLY, AND THE SYRINGE WAS ABLE TO DRAW AND EXPEL PROPERLY. 30 OUT OF THE REMAINING 293 RETURNED SYRINGES WERE TESTED FOR PLUNGER ROD MOVEMENT AND FLOW: ALL 30 TESTED PLUNGER RODS WERE ABLE TO MOVE PROPERLY, AND ALL 30 SYRINGES WERE ABLE TO DRAW AND EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED THE ALLEGED ISSUES COULD NOT BE CONFIRMED. THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT TO OPERATE (NOT DRAWING) AND PLUNGER ROD DIFFICULT TO MOVE 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. 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 AN UNSPECIFIED NUMBER OF SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DRAWING UP SOLUTION (METHAMPHETAMINE) IT WAS DIFFICULT AND THEN HARD TO PUSH ON PLUNGER. THE END USER HAS USED BD 1ML SYRINGES FOR MANY YEARS. HE HAS NOT EXPERIENCED A PROBLEM LIKE THIS BEFORE AND THE VISCOSITY OF THE SOLUTION HE DRAWS UP HAS NOT CHANGED. HE NOTICED WITH A NUMBER OF THE BD 1ML SYRINGES IT WAS DIFFICULT TO DRAW UP THE SOLUTION AND THEN ALSO VERY HARD TO PUSH ON THE PLUNGER.

    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 29GA 1/2IN BLS 500 AU EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DRAWING UP SOLUTION (METHAMPHETAMINE) IT WAS DIFFICULT AND THEN HARD TO PUSH ON PLUNGER. THE END USER HAS USED BD 1ML SYRINGES FOR MANY YEARS. HE HAS NOT EXPERIENCED A PROBLEM LIKE THIS BEFORE AND THE VISCOSITY OF THE SOLUTION HE DRAWS UP HAS NOT CHANGED. HE NOTICED WITH A NUMBER OF THE BD 1ML SYRINGES IT WAS DIFFICULT TO DRAW UP THE SOLUTION AND THEN ALSO VERY HARD TO PUSH ON THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333840 SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU SYRINGE FMF BD MEDICAL - DIABETES CARE 9140524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other