BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSULIN SYRINGE

    MDR report key: 14219192 · Received April 27, 2022

    Report

    Report Number
    1920898-2022-00289
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 10, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917025292
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 22-JUN-2022. INVESTIGATION SUMMARY: CUSTOMER RETURNED A SINGLE SYRINGE IN A POLYBAG LABELED FOR 1ML, 30 GAUGE, 8MM SYRINGE FROM LOT 0168471. THE SYRINGE WAS INSPECTED AND MEASURED TO ENSURE THAT USING IT WAS AS LEAST HARMFUL AS INTENDED. THE OUTER DIAMETER THE SYRINGE NEEDLE WAS MEASURED TO BE 0.0124 IN, WHICH IS WITHIN ACCEPTABLE OUTER DIAMETERS FOR 30 GAUGE NEEDLES (0.0120 IN TO 0.0125 IN). AN UNOPENED POLYBAG FOR 1ML, 30 GAUGE, 8MM SYRINGES FROM LOT 7331982 WAS ALSO RETURNED. NO DEFECTS WERE OBSERVED WITH THESE SYRINGES AND ASSOCIATED POLYBAG. ADDITIONALLY, NO SHELF CARTON WAS RETURNED FOR INSPECTION WITH THESE SAMPLES. NO SYRINGES, POLYBAGS, OR SHELF CARTONS FROM LOT 8071585 WERE RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8071585. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. EXPIRATION DATES WERE NOT PRINTED ON PACKAGING UNTIL 08NOV2019. EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF LABEL INFO MISSING AS THE SAMPLES RECEIVED WERE NOT FROM THE LOT IN QUESTION. PER MANUFACTURING, DATES NOT PRINTED ON POLYBAGS UNTIL NOV, 2019. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED 2 BD¿ INSULIN SYRINGES WERE MISSING THE EXPIRATION DATE ON THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NOT SEEING THE EXP DATE ON THIS BOX AND BAGS.

    Description of Event or Problem · 0

    IT WAS REPORTED 2 BD¿ INSULIN SYRINGES WERE MISSING THE EXPIRATION DATE ON THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NOT SEEING THE EXP DATE ON THIS BOX AND BAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097405 BD¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 928853 8071585 00311917025292

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown