BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE

    MDR report key: 10638975 · Received October 6, 2020

    Report

    Report Number
    1920898-2020-01360
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 14, 2020
    Report Date
    October 15, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249121
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) USED 31GX6MM, 1ML BD INSULIN SYRINGE FROM LOT 5243889. CONSUMER STATED THAT THE NEEDLE WAS BENT AT PATIENT END DURING INJECTION, AND STATED THAT THE INSULIN LEAKED FROM THE INJECTION SITE AFTER INJECTION. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE CANNULA WAS BENT. THIS SYRINGE WAS TESTED FOR POINT GEOMETRY, OUTER DIAMETER, AND LUBE COVERAGE (SPECS: OUTER DIAMETER FOR 31G CANNULA: 0.0100¿- 0.0105¿) AND THE FOLLOWING WAS OBSERVED: DATA: SAMPLE 1. POINT: GOOD. OUTER DIAMETER (IN.): 0.0102. LUBE: GOOD. THIS SYRINGE WAS THEN TESTED FOR FLOW, AND IT WAS OBSERVED THAT THE SYRINGE WAS ABLE DRAW AND EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE THIS SYRINGE WAS RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT CANNULA IS HUMAN FACTOR: IF THE USER REMOVES OR REATTACHES THE CANNULA SHIELD OBLIQUELY THEY MAY BEND THE CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 5243889. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200611400, 200611399] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CANNULA BENT). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (LEAKAGE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324912. BATCH NO. UNKNOWN (PROVIDED INVALID LOT #: 5243869). VERBATIM: CONSUMER STATED THAT THE NEEDLE WAS BENT AT PATIENT END DURING INJECTION. ALSO STATED THAT THE INSULIN LEAKED FROM THE INJECTION SITE AFTER INJECTION. CONSUMER PROVIDED LOT # AND PRODUCT #. SHE HAD DIFFICULTY READING THE LOT # FROM THE BAG, I ASKED HER TO SEND THE BAG WITH THE SAMPLE. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: NA. 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 AN UNSPECIFIED NUMBER OF BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324912 BATCH NO. UNKNOWN (PROVIDED INVALID LOT #: 5243869). VERBATIM: CONSUMER STATED THAT THE NEEDLE WAS BENT AT PATIENT END DURING INJECTION. ALSO STATED THAT THE INSULIN LEAKED FROM THE INJECTION SITE AFTER INJECTION. CONSUMER PROVIDED LOT # AND PRODUCT #. SHE HAD DIFFICULTY READING THE LOT # FROM THE BAG, I ASKED HER TO SEND THE BAG WITH THE SAMPLE. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097388 BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324912 5243889 00382903249121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other