BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 12865309 · Received November 23, 2021

    Report

    Report Number
    1920898-2021-01237
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 27, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11/19/2021. H.6. INVESTIGATION: CUSTOMER RETURNED 3 USED AND 3 UNUSED SYRINGES WITH A POLYBAG LABELED FOR 1.0ML, 31 GAUGE, 6MM SYRINGES FROM LOT 1033569. EACH OF THE SYRINGES WERE USED TO DRAW AND EXPEL WATER IN ORDER TO TEST THEIR FUNCTIONALITY. ALL OF THE PLUNGER RODS MOVED SMOOTHLY AND WITH LITTLE RESISTANCE. HOWEVER, ONE OF THE USED SYRINGES COULD NOT DRAW ANY FLUID. SUBMITTING SAMPLE TO MANUFACTURING FACILITY (B)(4) FOR FURTHER ANALYSIS REGARDING CLOG. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1033569. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO REPLICATE AND CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF A NEEDLE CLOG IN 1 OF THE RETURNED 6 SAMPLES. BASED ON THE SAMPLES RECEIVED, BD WAS UNABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE PLUNGERS BEING DIFFICULT TO MOVE. ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0

    IT WAS REPORTED THAT 6 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLES WERE UNABLE TO ASPIRATE OR HAD PLUNGER DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER STATED NOT ABLE TO DRAW MEDICATION AND WHEN TRYING TO DRAW MEDICATION, THE PLUNGER ROD SHOOTS BACK WITHOUT DRAWING ANYTHING UP. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLES WERE UNABLE TO ASPIRATE OR HAD PLUNGER DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER STATED NOT ABLE TO DRAW MEDICATION AND WHEN TRYING TO DRAW MEDICATION, THE PLUNGER ROD SHOOTS BACK WITHOUT DRAWING ANYTHING UP. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762128 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1033569

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown