BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 10171621 · Received June 18, 2020

    Report

    Report Number
    1213809-2020-00400
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 28, 2020
    Report Date
    August 17, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOS WERE AVAILABLE. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED NO DEFECTS COULD BE CONFIRMED AND NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT.

    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: 6/30/2020. H.6. INVESTIGATION: ONE PHOTO AND ONE LOOSE 1ML SYRINGE WERE RECEIVED AND EVALUATED. THE SYRINGE HAD FULL SCALE MARKINGS PRINTED ON THE BARREL. THE BARREL AND FLANGE WERE OBSERVED TO HAVE SEVERE DIAGONAL DAMAGE WITH SOME OF THE PLASTIC SHAVED OFF AROUND THE DAMAGED AREAS. THE DAMAGE APPEARED DIRECTIONAL FROM THE FLANGE DOWN THE BARREL ACROSS THE SCALE MARKINGS, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 0043415 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. A POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0043415 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION: ONE PHOTO WAS RECEIVED AND EVALUATED. THE PHOTO DEPICTED ONE LOOSE 1ML LL SYRINGE. THE SYRINGE HAD FULL SCALE MARKINGS PRINTED ON THE BARREL. THE BARREL AND FLANGE WERE OBSERVED TO HAVE SEVERE DIAGONAL DAMAGE WITH SOME OF THE PLASTIC SHAVED OFF AROUND THE DAMAGED AREAS. THE DAMAGE APPEARED DIRECTIONAL FROM THE FLANGE DOWN THE BARREL ACROSS THE SCALE MARKINGS. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 0043415 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. A POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0043415 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD 1ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED DEVICE DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: (B)(4). BATCH NO.: 0043415. THE CUSTOMER CALLED IN AND STATED HE HAD TWO SYRINGES THAT WERE MELTED / DEFORMED AT THE BARREL OF THE SYRINGE. SO FAR THESE ARE THE ONLY TWO THEY HAVE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD 1ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED DEVICE DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH NO.: 0043415. THE CUSTOMER CALLED IN AND STATED HE HAD TWO SYRINGES THAT WERE MELTED / DEFORMED AT THE BARREL OF THE SYRINGE. SO FAR THESE ARE THE ONLY TWO THEY HAVE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD 1ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED DEVICE DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628, BATCH NO.: 0043415. THE CUSTOMER CALLED IN AND STATED HE HAD TWO SYRINGES THAT WERE MELTED / DEFORMED AT THE BARREL OF THE SYRINGE. SO FAR THESE ARE THE ONLY TWO THEY HAVE FOUND.

    Additional Manufacturer Narrative · 1

    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 2 BD 1ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED DEVICE DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH NO.: 0043415. THE CUSTOMER CALLED IN AND STATED HE HAD TWO SYRINGES THAT WERE MELTED / DEFORMED AT THE BARREL OF THE SYRINGE. SO FAR THESE ARE THE ONLY TWO THEY HAVE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636017 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 0043415 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other