BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 11128957 · Received January 6, 2021

    Report

    Report Number
    1213809-2020-00952
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 4, 2020
    Report Date
    January 14, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-01-05. H6: INVESTIGATION SUMMARY: TWO 10ML SYRINGES WERE RECEIVED AND EVALUATED. ONE WAS LOOSE AND ONE WAS IN A FULLY SEALED BLISTER PACK FROM BATCH 0233943 (P/N 302995). IT WAS OBSERVED, THE LOOSE SYRINGE A LENGTHWISE CRACK IN THE BARREL EXTENDING FROM THE BOTTOM OF THE BARREL TO THE 8ML MARKING, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. NO DEFECTS WERE OBSERVED ON THE SYRINGE IN THE PACKAGE. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. (B)(4). NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0233943 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP WAS CRACKED AND LEAKED DURING THE INFUSION. THIS OCCURRED 2 SEPARATE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BARREL OF A 10 ML BD SYRINGE CRACKED DURING ADMINISTRATION OF AN IV MEDICATION. A 2.4 MG DOSE OF ONDANSETRON WAS DILUTED (VOLUME UNKNOWN) AND PLACED IN A 10 ML BD SYRINGE. THE SYRINGE WAS LOADED INTO AN ALARIS SYRINGE PUMP MODULE AND ADMINISTERED OVER 15 MINUTES. EXACT RATE UNKNOWN, BUT THE RATE COULD NOT HAVE EXCEEDED 40 ML/HR (MAX DILUTION 10 ML, OVER 15 MINUTES = 40 ML/HR). THE NURSE RETURNED AT THE END OF THE INFUSION IN ORDER TO ATTACH A FLUSH SYRINGE AND FLUSH THE LINE. THE 10 ML SYRINGE WAS WET AND THERE WAS A PUDDLE ON THE FLOOR BELOW WHERE THE SYRINGE WAS LOADED. UPON INSPECTION, A CRACK WAS DISCOVERED, APPOROXIMATELY 3 CM IN LENGTH RUNNING THE LENGTH OF THE BARREL. THE NURSE WHO PREPARED AND, SUBSEQUENTLY, ADMINISTERED THE MEDICATION DIDN'T RECALL ANYTHING UNUSUAL ABOUT THE SYRINGE WHEN FIRST REMOVING IT FROM IT'S PACKAGE FOR USE. THEY ALSO STATED THAT THE SYRINGE WAS NEVER MISHANDLED OR DROPPED."

    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 THE BD SYRINGE LUER-LOK¿ TIP WAS CRACKED AND LEAKED DURING THE INFUSION. THIS OCCURRED 2 SEPARATE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BARREL OF A 10 ML BD SYRINGE CRACKED DURING ADMINISTRATION OF AN IV MEDICATION. A 2.4 MG DOSE OF ONDANSETRON WAS DILUTED (VOLUME UNKNOWN) AND PLACED IN A 10 ML BD SYRINGE. THE SYRINGE WAS LOADED INTO AN ALARIS SYRINGE PUMP MODULE AND ADMINISTERED OVER 15 MINUTES. EXACT RATE UNKNOWN, BUT THE RATE COULD NOT HAVE EXCEEDED 40 ML/HR (MAX DILUTION 10 ML, OVER 15 MINUTES = 40 ML/HR). THE NURSE RETURNED AT THE END OF THE INFUSION IN ORDER TO ATTACH A FLUSH SYRINGE AND FLUSH THE LINE. THE 10 ML SYRINGE WAS WET AND THERE WAS A PUDDLE ON THE FLOOR BELOW WHERE THE SYRINGE WAS LOADED. UPON INSPECTION, A CRACK WAS DISCOVERED, APPROXIMATELY 3 CM IN LENGTH RUNNING THE LENGTH OF THE BARREL. THE NURSE WHO PREPARED AND, SUBSEQUENTLY, ADMINISTERED THE MEDICATION DIDN'T RECALL ANYTHING UNUSUAL ABOUT THE SYRINGE WHEN FIRST REMOVING IT FROM IT'S PACKAGE FOR USE. THEY ALSO STATED THAT THE SYRINGE WAS NEVER MISHANDLED OR DROPPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19089 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 0233943 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1