BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN

    MDR report key: 10882202 · Received November 22, 2020

    Report

    Report Number
    2243072-2020-01900
    Event Type
    Malfunction
    Date Received
    November 22, 2020
    Date of Event
    October 28, 2020
    Report Date
    January 26, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 12 BD ULTRA-FINE¿ INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN WERE MISSING THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN IT WAS REPORTED THAT NEEDLE IS MISSING FROM 12 SYRINGES. VERBATIM: CONSUMER REPORTED HAVING 12 SYRINGES WITH NO NEEDLE. STATED WHEN REMOVING THE ORANGE CAP, THERE IS NO NEEDLE THERE. STATED IT MIGHT BE STUCK IN THE ORANGE CAPS BECAUSE SHE SEES SOMETHING PLASTIC IN THE CAP. DISCARDED PRODUCT BOX AND POLY BAGS, UNABLE TO PROVIDE CAT # OR LOT #. STATED SHE IS USING THE 3/10ML, 8MM, 31G INSULIN SYRINGES. STATED SHE IS CONCERNED A NEEDLE IS GOING BREAK DURING HER INJECTION. CONSUMER USES MAIL ORDER PHARMACY, OFFERED TO SEND REPLACEMENT BOX TO DOCTOR'S OFFICE AND CONSUMER DECLINED REPLACEMENT. D.1. MEDICAL DEVICE BRAND NAME: BD ULTRA-FINE¿ INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN. D.3. MEDICAL DEVICE MANUFACTURER: BD MEDICAL - DIABETES CARE (HOLDREGE). D.4. MEDICAL DEVICE CATALOG#: 328291. D.4. MEDICAL DEVICE LOT #: 0090638. D.4. MEDICAL DEVICE EXPIRATION DATE: 4/30/2025. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: BD MEDICAL - DIABETES CARE (HOLDREGE). G.5. PMA / 510(K) #: K024112. H.4. DEVICE MANUFACTURE DATE: 03/30/2020. H.6. INVESTIGATION: CUSTOMER RETURNED SIX (6) 0.3ML BD INSULIN SYRINGES FROM OPEN POLYBAGS FROM LOT 0090638. CONSUMER REPORTED HAVING 12 SYRINGES WITH NO NEEDLE; STATED WHEN REMOVING THE ORANGE CAP, THERE IS NO NEEDLE THERE. ALL 6 RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT 3 SYRINGES EXHIBITED NEEDLE HUB/SHIELD ASSEMBLIES SEPARATED FROM THE BARREL; NO DAMAGE TO THE BARREL TIPS OF THESE 3 SYRINGES WAS OBSERVED. THE OTHER 3 RETURNED SYRINGES DID NOT EXHIBIT NEEDLE HUB SEPARATION, AND REMOVING THE CANNULA SHIELDS DID NOT RESULT IN HUB SEPARATION; IT WAS ALSO OBSERVED THAT THE CANNULA ON THESE 3 SYRINGES WAS NOT MISSING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0090638 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200894508] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE: ROOT CAUSE COULD NOT BE DETERMINED CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 12 BD ULTRA-FINE¿ INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN WERE MISSING THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN IT WAS REPORTED THAT NEEDLE IS MISSING FROM 12 SYRINGES. VERBATIM: CONSUMER REPORTED HAVING 12 SYRINGES WITH NO NEEDLE. STATED WHEN REMOVING THE ORANGE CAP, THERE IS NO NEEDLE THERE. STATED IT MIGHT BE STUCK IN THE ORANGE CAPS BECAUSE SHE SEES SOMETHING PLASTIC IN THE CAP. DISCARDED PRODUCT BOX AND POLY BAGS, UNABLE TO PROVIDE CAT # OR LOT #. STATED SHE IS USING THE 3/10ML, 8MM, 31G INSULIN SYRINGES. STATED SHE IS CONCERNED A NEEDLE IS GOING BREAK DURING HER INJECTION. CONSUMER USES MAIL ORDER PHARMACY, OFFERED TO SEND REPLACEMENT BOX TO DOCTOR'S OFFICE AND CONSUMER DECLINED REPLACEMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 12 UNSPECIFIED BD¿ SYRINGES WERE MISSING THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN. IT WAS REPORTED THAT NEEDLE IS MISSING FROM 12 SYRINGES. VERBATIM: CONSUMER REPORTED HAVING 12 SYRINGES WITH NO NEEDLE. STATED WHEN REMOVING THE ORANGE CAP, THERE IS NO NEEDLE THERE. STATED IT MIGHT BE STUCK IN THE ORANGE CAPS BECAUSE SHE SEES SOMETHING PLASTIC IN THE CAP. DISCARDED PRODUCT BOX AND POLY BAGS, UNABLE TO PROVIDE CAT # OR LOT #. STATED SHE IS USING THE 3/10ML, 8MM, 31G INSULIN SYRINGES. STATED SHE IS CONCERNED A NEEDLE IS GOING BREAK DURING HER INJECTION. CONSUMER USES MAIL ORDER PHARMACY, OFFERED TO SEND REPLACEMENT BOX TO DOCTOR'S OFFICE AND CONSUMER DECLINED REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346782 BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN SYRINGE FMF BD MEDICAL - DIABETES CARE 0090638

    Patients

    Seq Age Sex Outcome Treatment
    1