BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE 1ML 8MM 30G U-100 100COUNT

    MDR report key: 17119331 · Received June 13, 2023

    Report

    Report Number
    1920898-2023-00353
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 17, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2031514. D4. MEDICAL DEVICE EXPIRATION DATE: 28FEB2027. H4. DEVICE MANUFACTURE DATE: 31JAN2022. D4. MEDICAL DEVICE LOT #: 2276292. D4. MEDICAL DEVICE EXPIRATION DATE: 31OCT2027. H4. DEVICE MANUFACTURE DATE: 03OCT2022. D4. MEDICAL DEVICE LOT #: 1284135 D4. MEDICAL DEVICE EXPIRATION DATE: 31OCT2026 H4. DEVICE MANUFACTURE DATE: 11OCT2021 H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: 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# 2087950. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II INSULIN SYRINGE 1ML 8MM 30G U-100 100COUNT THE PRODUCT WAS DAMAGED WITH A CRACKED BARREL. THIS IS 1 OF 2 RELATED REPORTABLE MALFUNCTIONS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLES BENT. PAIN DURING INJECTIONS. PLUNGER ROD BROKEN. BARREL CRACKED. CONSUMER STATED THAT HE DOES NOT RE-USE CONSUMER ALSO STATED THAT THIS IS AN ONGOING ISSUE INVOLVING SEVERAL LOTS OF PRODUCT # 320469. CONSUMER REFUSED TO SEND IN SAMPLES, STATED THAT HE DOES NOT WANT TO BE BOTHERED WITH SENDING THEM IN. HE RECEIVED A MAIL KIT WITH HIS PREVIOUS COMPLAINT BUT DID NOT SEND SAMPLES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II INSULIN SYRINGE 1ML 8MM 30G U-100 100COUNT THE PRODUCT WAS DAMAGED WITH A CRACKED BARREL. THIS IS 1 OF 2 RELATED REPORTABLE MALFUNCTIONS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLES BENT. PAIN DURING INJECTIONS. PLUNGER ROD BROKEN. BARREL CRACKED. CONSUMER STATED THAT HE DOES NOT RE-USE CONSUMER ALSO STATED THAT THIS IS AN ONGOING ISSUE INVOLVING SEVERAL LOTS OF PRODUCT # 320469. CONSUMER REFUSED TO SEND IN SAMPLES, STATED THAT HE DOES NOT WANT TO BE BOTHERED WITH SENDING THEM IN. HE RECEIVED A MAIL KIT WITH HIS PREVIOUS COMPLAINT BUT DID NOT SEND SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251813 BD ULTRA-FINE¿ II INSULIN SYRINGE 1ML 8MM 30G U-100 100COUNT HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 2087950

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown