BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 10210440 · Received June 29, 2020

    Report

    Report Number
    1213809-2020-00427
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 8, 2020
    Report Date
    July 31, 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
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 5 BD 1ML SYRINGES LUER-LOK¿ TIPS EXPERIENCED DEVICE DAMAGE/DEFORMATION AND SCALE MARKING ISSUES. THE PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REJECTED FOR USE DUE TO SCRATCHES ON SYRINGE.

    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: 7/7/2020. H.6. INVESTIGATION: TEN PHOTOS AND EIGHT LOOSE 1ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED FIVE OF THE SYRINGES HAD A SMALL SCRATCH INSIDE THE GRAD LINES BETWEEN THE 0.08ML AND 0.09ML MARKINGS WITH TWO OF THEM ALSO HAVING A SIGNIFICANTLY SKEWED SCALE. THREE OF THE SYRINGES HAD MINOR SCUFFS OUTSIDE THE GRAD LINES. THE TWO SYRINGES WITH THE SKEWED SCALE CONDITION WERE REJECTABLE PER PRODUCT SPECIFICATION. ALL THE SCRATCHES AND SCUFFS WERE COSMETIC IN NATURE WITH NO EFFECT TO THE FORM FIT OR FUNCTION OF THE DEVICE AND WERE ACCEPTABLE PER PRODUCT SPECIFICATION. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 9232833 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. A POTENTIAL ROOT CAUSE FOR THE SCRATCHED BARREL DEFECT IS LIKELY ASSOCIATED WITH THE ASSEMBLY PROCESS AND THE SKEWED SCALE DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9232833 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD 1ML SYRINGES LUER-LOK¿ TIPS EXPERIENCED DEVICE DAMAGE/DEFORMATION AND SCALE MARKING ISSUES. THE PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REJECTED FOR USE DUE TO SCRATCHES ON SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD 1ML SYRINGES LUER-LOK¿ TIPS EXPERIENCED DEVICE DAMAGE/DEFORMATION AND SCALE MARKING ISSUES. THE PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REJECTED FOR USE DUE TO SCRATCHES ON SYRINGE.

    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 5 BD 1ML SYRINGES LUER-LOK¿ TIPS EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REJECTED FOR USE DUE TO SCRATCHES ON SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674267 BD 1ML SYRINGE LUER-LOK TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9232833 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other