BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6717202 · Received July 17, 2017

    Report

    Report Number
    1710034-2017-00117
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    June 30, 2017
    Report Date
    September 11, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LOT ANALYSIS DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). FINDINGS: AS THIS COMPLAINT WAS A MDR; -DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 7101570 ¿ THE LOT NUMBER WAS BUILT ON (B)(4). PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATIONS (B)(4), IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. QN / SAP DATABASE REVIEW: NO. REASON: A REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR A S1 - O1 LEVEL A INVESTIGATION PER (B)(4). THE PEURA (END USER RISK ANALYSIS): YES. REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: RM5835 REV 11 VERSION I WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. OBSERVATIONS: ALTHOUGH OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION, THERE WAS A PHOTOS SUPPLIED BY THE CUSTOMER THAT WAS REVIEWED. PHOTO ONE ¿ DISPLAYED A RETRACTED NEEDLE AND A 20GA CATHETER/ADAPTER IN THE NEEDLE COVER PHOTOS TWO ¿ DISPLAYED A RETRACTED NEEDLE IN A PLASTIC BAG WITH THE (B)(4). INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: UNKNOWN; THE UNIT DESCRIBED WITH THIS INCIDENT REPORT WAS NOT PROVIDED FOR EVALUATION. CONCLUSIONS: THE DEFECT OF CATHETER BROKE/SEPARATED AFTER PLACEMENT, AS STATED IN THE SUBJECT OF THE PRODUCT INCIDENT REPORT (PIR), COULD NOT BE CONFIRMED BASED ON THE REVIEW OF THE PHOTOS SUBMITTED BY THE CUSTOMER. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO; THE CUSTOMER EXPERIENCE WAS NOT CONFIRMED; BASED ON THE REVIEW OF THE PHOTOS SUBMITTED BY THE CUSTOMER. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; THE CUSTOMER EXPERIENCE WAS NOT REPRODUCED. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE ¿ THE PHOTOS PROVIDED FOR THIS INCIDENT DID NOT REVEAL THE REPORTED INCIDENT. COMMENT: WITHOUT A SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 A PATIENT FELL AND THE 20 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IN HIS FOREARM WAS CAUGHT BETWEEN HIS BED AND BEDSIDE TABLE. THE CATHETER BROKE OF IN THE PATIENT'S ARM AND HE HAD SURGERY TO REMOVE IT. THE INITIAL REPORTER ALSO STATES THAT THE PATIENT IS CURRENTLY "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497055 20 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7101570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention