BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 10566883 · Received September 22, 2020

    Report

    Report Number
    1911916-2020-00886
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    May 11, 2020
    Report Date
    October 5, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.3. DATE OF EVENT: 2020-09-10. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. B.5. DESCRIBE EVENT OR PROBLEM: THE EVENT DESCRIPTION HAS BEEN UPDATED WITH A NEW NUMBER OF OCCURRENCES, 10. G.4. DATE RECEIVED BY MANUFACTURER: 2020-09-10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 0031559. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 60ML SYRINGE LUER-LOK¿ TIP LEAKED PAST THE STOPPER. THIS OCCURRED ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309653 BATCH NO. 0031559. IT WAS REPORTED THAT MEDICATION LEAKED PAST RUBBER STOPPER. EVENT DESCRIPTION PER EMAIL STATES: BD 50ML SYRINGE, LOT NUMBER 0031559, EXP DATE 01/31/2025, HAS HAD SEVERAL SYRINGES LEAKING FROM THE RUBBER STOPPER INTO THE BARREL OF THE SYRINGE THESE SYRINGES WERE USED TO PREPARE CHEMOTHERAPY, WHICH COULD HAVE EXPOSED PHARMACY TECHNICIAN TO CHEMOTHERAPY DURING THE PREPARATION PROCESS. TECHNICIAN HAS NOTED 4 TO 5 SYRINGES WITH THE SAME PROBLEM, ALL FROM THE SAME LOT NUMBER FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 60ML SYRINGE LUER-LOK¿ TIP LEAKED PAST THE STOPPER. THIS OCCURRED ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309653 BATCH NO. 0031559 IT WAS REPORTED THAT MEDICATION LEAKED PAST RUBBER STOPPER. EVENT DESCRIPTION PER EMAIL STATES: BD 50ML SYRINGE, LOT NUMBER 0031559, EXP DATE 01/31/2025, HAS HAD SEVERAL SYRINGES LEAKING FROM THE RUBBER STOPPER INTO THE BARREL OF THE SYRINGE THESE SYRINGES WERE USED TO PREPARE CHEMOTHERAPY, WHICH COULD HAVE EXPOSED PHARMACY TECHNICIAN TO CHEMOTHERAPY DURING THE PREPARATION PROCESS. TECHNICIAN HAS NOTED 4 TO 5 SYRINGES WITH THE SAME PROBLEM, ALL FROM THE SAME LOT NUMBER FDA SAFETY REPORT ID# (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 19 MAY, 2020. MEDWATCH REPORT # MW5094483 REPORT SOURCE OTHER: MEDWATCH REPORT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD 60ML SYRINGE LUER-LOK¿ TIP LEAKED PAST THE STOPPER. THIS OCCURRED ON 5 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309653 BATCH NO. 0031559. IT WAS REPORTED THAT MEDICATION LEAKED PAST RUBBER STOPPER. EVENT DESCRIPTION PER EMAIL STATES: BD 50ML SYRINGE, LOT NUMBER 0031559, EXP DATE 01/31/2025, HAS HAD SEVERAL SYRINGES LEAKING FROM THE RUBBER STOPPER INTO THE BARREL OF THE SYRINGE THESE SYRINGES WERE USED TO PREPARE CHEMOTHERAPY, WHICH COULD HAVE EXPOSED PHARMACY TECHNICIAN TO CHEMOTHERAPY DURING THE PREPARATION PROCESS. TECHNICIAN HAS NOTED 4 TO 5 SYRINGES WITH THE SAME PROBLEM, ALL FROM THE SAME LOT NUMBER FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035684 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0031559 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other