BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3/10 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 11183212 · Received January 17, 2021

    Report

    Report Number
    1920898-2021-00083
    Event Type
    Malfunction
    Date Received
    January 17, 2021
    Date of Event
    December 27, 2020
    Report Date
    April 12, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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# 0141112. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 3/10 ML BD SAFETYGLIDE¿ INSULIN SYRINGES WITH ATTACHED NEEDLES EXPERIENCED PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305935, BATCH NO: 0141112. I'M GOING TO HAVE THIS LOT # PULLED FROM THE SUPPLY ROOMS TOMORROW AND SEGREGATED. WRITER ATTEMPTING TO PULL UP INSULIN INTO 30 UNIT BD SAFETYGLIDE (3/10ML 29G X 1/2) SYRINGE USING ASEPTIC TECHNIQUE, WRITER PULLED ON PLUNGER/PLUNGER FLANGE WHEN FLANGE (FLAT HEAD) POPPED OFF. WRITER ASSUMED HANDLING BY WRITER WAS THE CAUSE, OLD SYRINGE DISCARDED AND A NEW ONE WAS USED, WRITER REPEATED STEP AND THE SAME EVENT OCCURRED TWICE MORE. WRITER IS CONCERNED THAT FLANGE HEAD IS NOT THE ONLY PART OF THE SYRINGE THAT MAY COME LOOSE DURING ADMINISTRATION OF MED AND CAUSE HARM TO PATIENTS/STAFF.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 3/10 ML BD SAFETYGLIDE¿ INSULIN SYRINGES WITH ATTACHED NEEDLES EXPERIENCED PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305935 BATCH NO: 0141112. I'M GOING TO HAVE THIS LOT # PULLED FROM THE SUPPLY ROOMS TOMORROW AND SEGREGATED. WRITER ATTEMPTING TO PULL UP INSULIN INTO 30 UNIT BD SAFETYGLIDE (3/10ML 29G X 1/2) SYRINGE USING ASEPTIC TECHNIQUE, WRITER PULLED ON PLUNGER/PLUNGER FLANGE WHEN FLANGE (FLAT HEAD) POPPED OFF. WRITER ASSUMED HANDLING BY WRITER WAS THE CAUSE, OLD SYRINGE DISCARDED AND A NEW ONE WAS USED, WRITER REPEATED STEP AND THE SAME EVENT OCCURRED TWICE MORE. WRITER IS CONCERNED THAT FLANGE HEAD IS NOT THE ONLY PART OF THE SYRINGE THAT MAY COME LOOSE DURING ADMINISTRATION OF MED AND CAUSE HARM TO PATIENTS/STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79827 3/10 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE SYRINGE, ANTISTICK MEG BD MEDICAL - DIABETES CARE 0141112

    Patients

    Seq Age Sex Outcome Treatment
    1