BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6828073 · Received August 29, 2017

    Report

    Report Number
    1710034-2017-00162
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    August 7, 2017
    Report Date
    August 21, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CORRECTIVE ACTION STATEMENT IS APPROVED/AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY DESIGNATED COMPLAINT HANDLING UNIT. INVESTIGATION COMPLETED BY: (B)(4) PIR #: 121243 (126749) ¿ MDR NO SAMPLE, PART #: 381523, LOT #: 7121750, COMPLAINT: 1 - NEEDLE RETRACTION FAILURE, 2 - NEEDLE STICKS INJURY. CUSTOMER VERBATIM: BD CAT# 381523 INSIDE IV CATH 22GX1 - NEEDLE DID NOT RETRACT FULLY AND NURSE WAS STUCK WITH NEEDLE. LOT# 7121750 DO NOT HAVE PRODUCT TO RETURN. 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: 7121750 ¿ THE LOT NUMBER WAS BUILT ON AFA LINE 5, FROM MAY 4, 2017 THRU MAY 8, 2017. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATIONS S-AU33, S-AU34, S-AU35 AND S-AU36, 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: YES. REASON: A REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR A S2-O1 LEVEL A INVESTIGATION PER CPR ¿ 071. 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. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION. TEST DESCRIPTION: N/A, METHOD NO: N/A RESULTS: N/A. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: UNKNOWN; (UNITS WERE NOT RECEIVED FOR EVALUATION AND TESTING). CONCLUSION: ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. 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. UDI#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE WAS STUCK WITH A 22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DURING USE DUE TO RETRACTION FAILURE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607266 22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7121750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other