BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGES 3/10ML

    MDR report key: 9077781 · Received September 17, 2019

    Report

    Report Number
    1920898-2019-00999
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    September 3, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908431033
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9007820, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-01-07. MEDICAL DEVICE LOT #: 8240653. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-08-28. LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE POINT DULL, NEEDLE POINT BLUNT AND DIFFICULT/UNABLE TO OPERATE (UNABLE TO INJECT MEDICINE) ON LOT # 90078220 AND LOT # 8240653. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9007820. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8240653. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGES 3/10ML ARE UNABLE TO INJECT MEDICATION. THIS OCCURRED ON 33 OCCASIONS DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328431, BATCH NO: 9007820, 8240653. IT WAS REPORTED THAT THE NEEDLES ARE DULL / BLUNT AND UNABLE TO INJECT MEDICATION. PET OWNER REPORTED DULL NEEDLES OR NO POINT ON SYRINGES. WHEN SHE TRIES TO INJECT ON TO THE PET SHE NOTICES THE POINT IS DULL WHEN SHE IS UNABLE TO INJECT THE MEDICINE. SAMPLE DISCARDED. EVERY POLY BAG HAS 3-4 DULL SYRINGES AND NOW SHE IS USING THE LAST POLY BAG. ADVISED THE PET OWNER TO SAVE THE SAMPLE IF RE OCCURRENCE. OFFERED TO SEND 2 VOUCHERS. PET OWNER ALWAYS USES THE NEW NEEDLE FOR INJECTION AND ROTATES THE INJECTION SITE. SHE VISUALLY TESTS THE NEEDLE BUT DO NOT KNOW UNTIL SHE TRIES TO USE IT ON THE CAT IF THE NEEDLE IS DULL OR NOT, SHE WIPES OFF THE NEEDLE WITH THE SWAB SINCE SHE IS NOT ABLE TO WIPE CATS SKIN SOMETIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872636 BD ULTRA-FINE INSULIN SYRINGES 3/10ML PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 00382908431033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other