BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 8967211 · Received September 5, 2019

    Report

    Report Number
    1911916-2019-00918
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 19, 2019
    Report Date
    October 2, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: D.3. MEDICAL DEVICE MANUFACTURER: COLUMBUS.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO (2) SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. HOWEVER, AS THE SAMPLES HAD BEEN USED WITH AN UNKNOWN DRUG, LEAKAGE TESTING WAS UNABLE TO BE PERFORMED DUE TO POSSIBLE CONTAMINATION OF THE TESTING EQUIPMENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. LEAKAGE CAN BE CAUSED BY THE INTERACTION BETWEEN THE BARREL INSIDE DIAMETER, THE STOPPER OUTSIDE DIAMETER, AND PLUNGER ROD BAYONET OUTSIDE DIAMETER AND FORCES APPLIED DURING USE. THE SYRINGE IS MORE LIKELY TO LEAK WHEN FORCES ARE APPLIED TO THE PLUNGER ROD WHEN FULLY EXTENDED. CORRECTIVE AND PREVENTATIVE ACTION 55639 WAS OPENED TO INVESTIGATE. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 60ML SYRINGE LUER-LOK¿ TIP LEAKED. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309653; BATCH NO.: 8220725, 9086666. IT WAS REPORTED LEAKING OUT OF THE BACK END OF THE PLUNGER. PER EMAIL ON 19-AUG-2019: THE LOT IS NOT KNOWN FOR THE (B)(6) 2019 EVENT. I HAVE RECEIVED 2 MORE SYRINGES WITH ISSUES ON MY DESK. AFFECTED TIME WOULD BE FROM 8/12 ¿ 8/16. THE TECHNICIAN WAS DRAWING UP SOLUTION AND NOTICED THEY WERE LEAKING OUT OF THE BACK END OF THE PLUNGER

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 60ML SYRINGE LUER-LOK¿ TIP LEAKED. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309653; BATCH NO.: 8220725, 9086666. IT WAS REPORTED LEAKING OUT OF THE BACK END OF THE PLUNGER. PER EMAIL ON 19-AUG-2019: THE LOT IS NOT KNOWN FOR THE (B)(6) 2019 EVENT. I HAVE RECEIVED 2 MORE SYRINGES WITH ISSUES ON MY DESK. AFFECTED TIME WOULD BE FROM 8/12 ¿ 8/16. THE TECHNICIAN WAS DRAWING UP SOLUTION AND NOTICED THEY WERE LEAKING OUT OF THE BACK END OF THE PLUNGER.

    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 #: 8220725. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-08-08. MEDICAL DEVICE LOT #: 9086666. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-03-27. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD 60ML SYRINGE LUER-LOK¿ TIP LEAKED. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309653, BATCH NO.: 8220725, 9086666. IT WAS REPORTED LEAKING OUT OF THE BACK END OF THE PLUNGER. PER EMAIL ON 19-AUG-2019: THE LOT IS NOT KNOWN FOR THE (B)(6) 2019 EVENT. I HAVE RECEIVED 2 MORE SYRINGES WITH ISSUES ON MY DESK. AFFECTED TIME WOULD BE FROM 8/12 ¿ 8/16 THE TECHNICIAN WAS DRAWING UP SOLUTION AND NOTICED THEY WERE LEAKING OUT OF THE BACK END OF THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761789 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other