BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK¿ TIP

    MDR report key: 12510875 · Received September 21, 2021

    Report

    Report Number
    1213809-2021-00647
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 12, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-11-16. H6: INVESTIGATION SUMMARY FOUR PHOTOS AND ONE 1ML LUER-LOCK SYRINGE (P/N 309628) SEALED IN A BLISTER PACKAGE FROM BATCH #9092983 WERE RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. IT WAS IMMEDIATELY OBSERVED THAT THE SYRINGE SCALE WAS SEVERELY SKEWED AND MISPLACED. THESE CONDITIONS ARE NON-CONFORMING PER PRODUCT SPECIFICATION. MACHINE LOGS AND PRODUCTION RECORDS WERE REVIEWED AS PART OF THIS INVESTIGATION. ADDITIONALLY, A TECHNICIAN SUPERVISOR WAS ALSO INTERVIEWED CONCERNING THE DEFECT. THE ISSUE WAS PROPERLY IDENTIFIED DURING OPERATION AND RESPONDED TO APPROPRIATELY AS A WORN PAD WHEEL. PRINTING PADS CAN BECOME WORN FOR NUMEROUS REASONS INCLUDING OVERUSE AND IMPROPER MAINTENANCE OF THE INK VISCOSITY SYSTEM. THESE ISSUES CAN RESULT IN PAD SWELLING THAT CAN NEGATIVELY IMPACT THE PRINT IN A VARIETY OF WAYS INCLUDING SKEWED AND MISPLACED SCALE. ADEQUATE CONTROLS ARE IN PLACE TO ENSURE THAT PRINTING PADS ARE RETIRED OR CHANGED DURING MANUFACTURING AND TO MONITOR INK VISCOSITY. HOWEVER, IT WAS ALSO NOTED THAT THE SAMPLE SIZE USED IN THE REQUALIFICATION UTILIZED ANSI/ASQ Z1.4 LEVEL 2 NORMAL PLAN WHICH MAY NOT HAVE BEEN ADEQUATE TO PROPERLY CONTAIN THE ISSUE. POTENTIAL ROOT CAUSE FOR THE SKEWED AND MISPLACED SCALE DEFECTS IS ASSOCIATED WITH THE MARKING PROCESS. THE ISSUE WAS IMMEDIATELY CORRECTED WITH THE PAD WHEEL REPLACEMENT AND RESPONDED TO APPROPRIATELY DURING BATCH PRODUCTION VIA REQUALIFICATION OF AFFECTED PRODUCT. HOWEVER, IT IS POSSIBLE THAT A LIMITED AMOUNT OF THE AFFECTED PRODUCT ESCAPED DETECTION AND WERE PROCESSED THROUGH THE PACKAGING MACHINERY WERE THEY FURTHER WENT UNDETECTED. THE FOLLOWING CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED SINCE MANUFACTURE OF THIS BATCH TO HELP PREVENT THESE ISSUES FROM REACHING THE CUSTOMER: 1) ALL REQUALIFICATION'S RESULTING FROM SCALE MARKING DEFECTS NOW BE REQUIRED TO FOLLOW AN ANSI/ASQ Z1.4 LEVEL 2 TIGHTENED SAMPLING PLAN. IMPLEMENTED: (B)(6) 2019. 2) INK VISCOSITY IS NOW REQUIRED TO BE TESTED AND VALUE RECORDED AT LEAST ONCE PER OPERATING SHIFT TO ENSURE OPTIMAL VALUES. IMPLEMENTED: (B)(6) 2021. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 1ML SYRINGE LUER-LOK¿ TIP EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING A DISCUSSION, A SCALE MARKING ISSUE WAS NOTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN:  (B)(6) USA HAS BEEN USED AS A DEFAULT.  A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD 1ML SYRINGE LUER-LOK¿ TIP EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING A DISCUSSION, A SCALE MARKING ISSUE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407987 BD 1ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9092983 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown