BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 10591127 · Received September 26, 2020

    Report

    Report Number
    1213809-2020-00665
    Event Type
    Malfunction
    Date Received
    September 26, 2020
    Date of Event
    August 18, 2020
    Report Date
    October 12, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: H.6. INVESTIGATION: SIXTY 3ML SYRINGES IN FULLY SEALED BLISTER PACKS FROM BATCH 0150246 WERE RECEIVED AND EVALUATED. IT WAS OBSERVED FIFTY-NINE OF THE SYRINGES WERE COMPLETELY BLANK AND ONE SYRINGE CONTAINED PORTIONS OF A PRINTED SCALE WITH AREAS OF MISSING SCALE BETWEEN THE 1ML AND 2ML MARKINGS AS WELL AS THE 2.5ML AND 3ML MARKINGS. ALL THE SYRINGES RECEIVED WERE MISSING MORE THAN 50% OF ANY ONE PRINTED ITEM, WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE EQUIPMENT FAILURE. THERE WAS LIKELY AND INK PUMP FAILURE THAT QUICKLY STOPPED THE INK FLOW, PREVENTING INK FROM BEING APPLIED TO THE BARRELS. MISSING PRINT WAS FOUND DURING THE MANUFACTURE OF THIS BATCH AND A REQUALIFICATION WAS PERFORMED. IT IS POSSIBLE A SMALL NUMBER OF SYRINGES WERE ABLE TO ESCAPE DETECTION. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH A REQUALIFICATION FOR MISSING PRINT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: G.4. DATE RECEIVED BY MANUFACTURER: 2020-09-10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP WAS MISSING SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657; BATCH NO.: 0150246. IT WAS REPORTED THAT: SCALE MARKING ISSUE. EVENT DESCRIPTION PER EMAIL STATES: "BD 3 ML LUER_LOK SYRINGE, LOT 0150246 DOES NOT HAVE ANY INK ON THE SYRINGE TO MARK THE MEASUREMENTS. SOME NURSES REPORTED FINDING THESE SEALED UNMARKED SYRINGES IN PREVIOUS DAYS. SIXTY-ONE SYRINGES IN OUR FLOOR STOCK THAT HAD THIS DEFECT. THEY HAVE BEEN REMOVED FROM THE FLOOR STOCK AND OUR SUPPLY MANAGER NOTIFIED." THE MEDWATCH REPORTED WAS RECEIVED IN FRANKLIN LAKES ON 03-SEP-2020 AND IT REFLECTED IN THE AWARENESS DATE. THE REPORT WAS NOT SENT TO THE RCC UNTIL 09/17/2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP WAS MISSING SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO.: 0150246. IT WAS REPORTED THAT: SCALE MARKING ISSUE. EVENT DESCRIPTION PER EMAIL STATES: "BD 3 ML LUER_LOK SYRINGE, LOT 0150246 DOES NOT HAVE ANY INK ON THE SYRINGE TO MARK THE MEASUREMENTS. SOME NURSES REPORTED FINDING THESE SEALED UNMARKED SYRINGES IN PREVIOUS DAYS. SIXTY-ONE SYRINGES IN OUR FLOOR STOCK THAT HAD THIS DEFECT. THEY HAVE BEEN REMOVED FROM THE FLOOR STOCK AND OUR SUPPLY MANAGER NOTIFIED." THE MEDWATCH REPORTED WAS RECEIVED IN FRANKLIN LAKES ON 03-SEP-2020 AND IT REFLECTED IN THE AWARENESS DATE. THE REPORT WAS NOT SENT TO THE RCC UNTIL 09/17/2020.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 1 SEPTEMBER, 2020. MEDWATCH REPORT # MW5096155. 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 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP WAS MISSING SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657, BATCH NO.: 0150246. IT WAS REPORTED THAT: SCALE MARKING ISSUE. EVENT DESCRIPTION PER EMAIL STATES: "BD 3 ML LUER_LOK SYRINGE, LOT 0150246 DOES NOT HAVE ANY INK ON THE SYRINGE TO MARK THE MEASUREMENTS. SOME NURSES REPORTED FINDING THESE SEALED UNMARKED SYRINGES IN PREVIOUS DAYS. SIXTY-ONE SYRINGES IN OUR FLOOR STOCK THAT HAD THIS DEFECT. THEY HAVE BEEN REMOVED FROM THE FLOOR STOCK AND OUR SUPPLY MANAGER NOTIFIED." THE MEDWATCH REPORTED WAS RECEIVED IN (B)(4) ON 03-SEP-2020 AND IT REFLECTED IN THE AWARENESS DATE. THE REPORT WAS NOT SENT TO THE RCC UNTIL 09/17/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055685 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 0150246 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other