BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE HEPARIN 27GAX1/2 1ML

    MDR report key: 9233622 · Received October 24, 2019

    Report

    Report Number
    1920898-2019-01188
    Event Type
    Malfunction
    Date Received
    October 24, 2019
    Date of Event
    October 10, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (3) LOOSE 1ML BD SYRINGE LABELED FOR CALCIPARINE FROM LOT # 7177608. CUSTOMER STATES THAT THE PRINTING IS THICKER THAN EXPECTED AND THERE IS A PRESENCE OF A LIQUID. ALL RETURNED SYRINGES WERE EXAMINED AND ALL SAMPLES EXHIBITED SMEARED SCALE MARKINGS PRINTED ON THE BARREL. HOWEVER, NO SAMPLE EXHIBITED ANY FOREIGN MATTER IN OR ON THE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7177608. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. UNABLE TO DETERMINE THE ROOT CAUSE OF THE SMEARED PRINT. CAPA#162566 WAS OPENED ON 25OCT2017 AFTER THE DATE OF MANUFACTURE TO ADDRESS PRINTING DEFECTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE HEPARIN 27GAX1/2 1ML THERE WERE SCALE MARKING ISSUES AND ISSUES WITH FOREIGN MATTER. THERE WERE 10 SYRINGES WITH THESE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PRINTING THICKER THAN EXPECTED ON PLASTIC. PRESENCE OF LIQUID. 10 SYRINGES DETECTED IN 1 BOX. NO DATA ON THE WHOLE LOT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE HEPARIN 27GAX1/2 1ML THERE WERE SCALE MARKING ISSUES AND ISSUES WITH FOREIGN MATTER. THERE WERE 10 SYRINGES WITH THESE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: PRINTING THICKER THAN EXPECTED ON PLASTIC. PRESENCE OF LIQUID. 10 SYRINGES DETECTED IN 1 BOX. NO DATA ON THE WHOLE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030890 SYRINGE HEPARIN 27GAX1/2 1ML SYRINGE FMF BD MEDICAL - DIABETES CARE 7177608

    Patients

    Seq Age Sex Outcome Treatment
    1 Other