BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK WITH NEEDLE

    MDR report key: 7558723 · Received May 31, 2018

    Report

    Report Number
    1213809-2018-00351
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 22, 2018
    Report Date
    May 31, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903052708
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. ADDITIONAL INFORMATION WAS RECEIVED FOR THE MEDICAL DEVICE LOT NUMBER(S), CATEGORY NUMBER (S), MANUFACTURING/EXPIRATION DATE(S), MANUFACTURING LOCATION. THE FOLLOWING FIELD(S) HAVE BEEN UPDATED: D.1. MEDICAL DEVICE BRAND NAME: BD¿ LUER-LOK WITH NEEDLED.2. MEDICAL DEVICE TYPE:FMF, D.3. MEDICAL DEVICE MANUFACTURER: CANNAN, D.4. COMMON DEVICE NAME: PISTON SYRINGE, D.4. MEDICAL DEVICE LOT #:7093501, D.4. MEDICAL DEVICE CAT #: 309571, D.4. UDI: 30382903095712, D.4. MEDICAL DEVICE EXPIRATION DATE: 03/31/2022. G.1. MANUFACTURING LOCATION: CANNAN, G.5. 510K: K980987, H.4. DEVICE MANUFACTURE DATE: 2017-04-03. THE MEDICAL DEVICE MANUFACTURER LOCATION FOR THIS DEVICE IS CANAAN, MANUFACTURER SITE NO. 1213809. THE FOLLOWING FIELDS HAVE BEEN UPDATED TO REFLECT THE UPDATED MANUFACTURING SITE. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL SYSTEM, G.1. MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL SYSTEMS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. INVESTIGATION CONCLUSION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. DHR REVIEW FOR BATCH 7235628 (P/N 305270): MANUFACTURING DATES: 09/21/2017 TO 09/23/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7235628 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ROOT CAUSE DESCRIPTION: ROOT CAUSE AND CAPA NOT REQUIRED AS NO DEFECTS WERE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE MALFUNCTIONED AS THE NEEDLE RETRACTION FAILED "AND REMAINS INSIDE THE PATIENT. THE PATIENT RECEIVED AN INJECTION ON (B)(6) 2018 AT THE (B)(6) HEALTH CENTER AND WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM. THE HEALTHCARE STAFF STATED THE EMERGENCY ROOM REFERRED THE PATIENT TO AN ORTHOPEDIC SURGEON TO GET THE NEEDLE REMOVED. THE HEALTHCARE STAFF DOES NOT KNOW IF/WHAT TREATMENT THE PATIENT RECEIVED AT THE EMERGENCY ROOM. NO FURTHER INFORMATION IS AVAILABLE IN REGARDS TO WHAT MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401736 BD¿ LUER-LOK WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7093501 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention