BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 10169276 · Received June 18, 2020

    Report

    Report Number
    1213809-2020-00396
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS DEPICTED AN INFUSION BAG WITH CLEAR LIQUID INSIDE. A SMALL BLACK PARTICLE WAS OBSERVED INSIDE THE BAG. ONE OF THE PHOTOS SHOWED A CLOSE-UP OF THE BAG AND THE PARTICLE. THE INFUSION BAG IS NOT A BD CANAAN PRODUCT. NO BD PRODUCTS WERE DEPICTED IN THE PHOTO AND NO DEFECTS COULD BE CONFIRMED WITH THE 10ML BD SYRINGE PRODUCT. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 9268529 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE AVAILABLE EVIDENCE TODAY, THE REPORTED DEFECT COULD NOT BE CONFIRMED TO HAVE ORIGINATED DURING THE SYRINGE MANUFACTURING PROCESS. NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE BLACK FOREIGN MATTER WAS DISCOVERED WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I.R. OF THE RELEASE TEST OF THE PREPARED PREPARATION (PEMBROLIZUMAB INFUSION SOLUTION 100 ML) A BLACK PARTICLE (DIAMETER APPROX. 1 MM) WAS DETECTED IN THE INFUSION SOLUTION. THE PREPARATION WAS THEN DISCARDED. THE FOLLOWING MATERIALS WERE USED FOR THE PRODUCTION: KEYTRUDA 100 MG CH.B. T005361 VD 08/21 PZN: 10749897; NACL 0,9 % FREEFLEX 100 ML CH.B. 13NIS021 VD 08/21; 1.2 M BROWN INTRAPUR LIPID FILTER CH.B. 19L15F0000; CODAN SPIKE (MICRO SPIKE) CH.B. M86186-1 VD 09/23 REF 16.5206; BD 10ML SYRINGE LUER-LOK TIP LOT 9268529 (C03) REF 300912; CONNECT Z (FA. BRAUN) CH.B. 1178364.1 VD: 12/24. AFTER TESTING THE STARTING MATERIALS USED, BD 10ML SYRINGE LUER-LOK TIP LOT 9268529 (C03) REF 300912 WAS FOUND TO BE THE MOST LIKELY SOURCE OF CONTAMINATION. AFTER VISUAL INSPECTION, THE NATURE OF THE PARTICLE RESEMBLES THE MATERIAL OF THE BLACK SEALING RING.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE BLACK FOREIGN MATTER WAS DISCOVERED WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I.R. OF THE RELEASE TEST OF THE PREPARED PREPARATION (PEMBROLIZUMAB INFUSION SOLUTION 100 ML) A BLACK PARTICLE (DIAMETER APPROX. 1 MM) WAS DETECTED IN THE INFUSION SOLUTION. THE PREPARATION WAS THEN DISCARDED. THE FOLLOWING MATERIALS WERE USED FOR THE PRODUCTION: KEYTRUDA 100 MG CH.B. (B)(4) VD 08/21 PZN: (B)(4). NACL 0,9 % FREEFLEX 100 ML CH.B. (B)(4) VD 08/21. 1.2 M BROWN INTRAPUR LIPID FILTER CH.B. (B)(4). CODAN SPIKE (MICRO SPIKE) CH.B. (B)(4) VD 09/23 REF (B)(4). BD 10ML SYRINGE LUER-LOK TIP LOT 9268529 (C03) REF 300912. CONNECT Z (FA. BRAUN) CH.B. (B)(4) VD: 12/24. AFTER TESTING THE STARTING MATERIALS USED, BD 10ML SYRINGE LUER-LOK TIP LOT 9268529 (C03) REF 300912 WAS FOUND TO BE THE MOST LIKELY SOURCE OF CONTAMINATION. AFTER VISUAL INSPECTION, THE NATURE OF THE PARTICLE RESEMBLES THE MATERIAL OF THE BLACK SEALING RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635991 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 300912 9268529 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other