BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB

    MDR report key: 9318513 · Received November 13, 2019

    Report

    Report Number
    8041187-2019-00918
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 3, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057871
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB HAS BEEN FOUND CONTAINING FOREIGN MATTER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN DRAWING THE PLUNGER IS STICKING A BIT. SOME SORT OF RESIDE, BUBBLY LINE WHERE THE RUBBER STOPPER IS. VERBATIM: WHEN DRAWING THE PLUNGER IS STICKING A BIT. SOME SORT OF RESIDUE, BUBBLY LINE WHERE THE RUBBER STOPPER IS. 3 BOXES OF 50. ITEM: 305787. LOT: 8082064. STICKY CLEAR RESIDUE/LIQUID INSIDE THE BARREL OF SYRINGES STATED, BARELY VISIBLE BUT UNDER LIGHT, YOU CAN SEE A CLEAR LINE NEXT TO THE STOPPER STATED, HARD TO PUSH PLUNGER ROD BECAUSE OF STICKY RESIDUE/LIQUID INSIDE BARREL STATED, SOME OF THE RESIDUE IS "BUBBLY". STATED, SHE HAS 3 BOXES WITH SAME LOT, EXPIRATION AND REFERENCE NUMBER ONLY 2 BOXES AFFECTED, (40 SYRINGES BETWEEN THE TWO BOXES). ONE INCIDENT DATE (B)(6) 2019. EXPIRATION DATE: 2023-03-31. ITEM: 305787. 3 ML BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY 25 G X 1 IN. THIN WALL NEEDLE, STERILE, SINGLE USE.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K980987 / K161170. 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 HAS BEEN REPORTED THAT THE SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB HAS BEEN FOUND CONTAINING FOREIGN MATTER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN DRAWING THE PLUNGER IS STICKING A BIT. SOME SORT OF RESIDE, BUBBLY LINE WHERE THE RUBBER STOPPER IS. VERBATIM: WHEN DRAWING THE PLUNGER IS STICKING A BIT. SOME SORT OF RESIDUE, BUBBLY LINE WHERE THE RUBBER STOPPER IS. 3 BOXES OF 50. ITEM: 305787. LOT: 8082064. STICKY CLEAR RESIDUE/LIQUID INSIDE THE BARREL OF SYRINGES. STATED, BARELY VISIBLE BUT UNDER LIGHT, YOU CAN SEE A CLEAR LINE NEXT TO THE STOPPER STATED, HARD TO PUSH PLUNGER ROD BECAUSE OF STICKY RESIDUE/LIQUID INSIDE BARREL STATED, SOME OF THE RESIDUE IS "BUBBLY". STATED, SHE HAS 3 BOXES WITH SAME LOT, EXPIRATION AND REFERENCE NUMBER ONLY 2 BOXES AFFECTED, (40 SYRINGES BETWEEN THE TWO BOXES). ONE INCIDENT DATE: (B)(6) 2019. EXPIRATION DATE: 2023-03-31. ITEM: 305787. 3 ML BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY 25 G X 1 IN. THIN WALL NEEDLE, STERILE, SINGLE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108469 SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8082064 30382903057871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other