BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7129514 · Received December 19, 2017

    Report

    Report Number
    1710034-2017-00460
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    November 27, 2017
    Report Date
    January 23, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: TWO SAMPLE UNITS WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, NO DAMAGE WAS OBSERVED TO THE FIRST UNIT AND THE SECOND UNIT HAD A PIECE OF CATHETER TUBING SEPARATED WITH ROUGH EDGES. IT IS UNCERTAIN WHETHER THE DEFECT OBSERVED ON UNIT TWO WAS CAUSED BY MANIPULATION OF THE DEVICE PRIOR TO INSERTION OR AFTER INSERTION. THE ROUGH EDGES ON THE SEPARATED PIECES OF TUBING ARE AN INDICATION OF TENSILE STRESS ON THE CATHETER TUBING. LOT ANALYSIS. DEVICE/BATCH HISTORY RECORD REVIEW: NO. REASON: ALTHOUGH THE INVESTIGATION IS MDR, THE LOT NUMBER ASSOCIATED WITH THE INCIDENT WAS NOT REPORTED. FINDINGS: N/A SAP (QN) DATABASE REVIEW: NO. REASON: THIS DATABASE TRACKS ANY ISSUE DURING PRODUCTION THAT WOULD AFFECT PRODUCT QUALITY. FINDINGS: SUBJECT CODE WAS AN S3 SEVERITY RANKING. REVIEW WAS NOT CONDUCTED FOR THIS MDR- LEVEL B INVESTIGATION BECAUSE A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. THE PEURA (END USER RISK ANALYSIS): YES. REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: RM5835 REVISION 12 VERSION J WAS REVIEWED AND DETERMINED TO HAVE APPROPRIATE ASSESSMENT OF RISK RELATED TO THIS DEFECT. VISUAL ANALYSIS. OBSERVATIONS AND TESTING: RECEIVED TWO USED 22G INSYTE AUTOGUARD IV CATHETER/ADAPTER UNITS AND A MEDICINE CONTAINER WITH A PIECE OF CATHETER TUBING IN IT. VISUAL/MICROSCOPIC EVALUATION REVEALED: UNIT 1: OBSERVED THERE WAS TRACES OF BLOOD RESIDUE ON THE CATHETER TUBING, INSIDE THE ADAPTER (WEDGE/TUBING ASSEMBLY AREA), NO DAMAGE WAS OBSERVED ON ANY OF ITS COMPONENTS AND THE CATHETER TUBING WAS INTACT (NO HOLES, CUTS OR DEFECTS). (B)(4). UNIT 2: OBSERVED THERE WERE TRACES OF BLOOD RESIDUE ON THE CATHETER TUBING, INSIDE THE ADAPTER (WEDGE/TUBING ASSEMBLY AREA) AND ON THE WINGS. OBSERVED THERE WAS APPROXIMATELY 11MM OF CATHETER TUBING (FROM THE NOSE OF THE ADAPTER TO THE HIGHEST POINT OF THE TUBING) AND THE CATHETER TIP WAS SEPARATED, THE PIECE OF CATHETER TUBING RECEIVED IN THE MEDICINE CONTAINER MATCHED THE TUBING ON THE ADAPTER, THE AREA OF SEPARATION AT THE CATHETER TUBING HAD ROUGH EDGES ON BOTH OF THE PIECES OF THE CATHETER TUBING. (B)(4). WATER-LEAK TEST: THE WATER LEAK TEST WAS PERFORMED ONLY ON UNIT 1, NO LEAKAGE WAS OBSERVED ON ANY OF THE AREAS OF THE UNIT CONFIRMING NO DAMAGE WAS PRESENT. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO. UNIT 2 SEPARATION ON THE CATHETER TUBING WAS OBSERVED. THE AREA OF SEPARATION AT THE CATHETER TUBING HAD ROUGH EDGES ON BOTH OF THE PIECES RECEIVED. CONCLUSIONS: NO DEFECTS WERE FOUND ON UNIT 1. THE DEFECT OF CATHETER BROKE, AS STATED IN THE PRODUCT INCIDENT REPORT WAS CONFIRMED WITH UNIT 2. THE AREA OF SEPARATION AT THE CATHETER TUBING HAD ROUGH EDGES ON BOTH OF THE PIECES RECEIVED, AN INDICATION OF TENSILE STRESS ON THE CATHETER TUBING. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? YES: THE DEFECT EXPERIENCED BY THE CUSTOMER WAS CONFIRMED ON UNIT 2. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO: THE CUSTOMER¿S EXPERIENCE WAS NOT REPRODUCED IN THE LABORATORY ENVIRONMENT. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. CONCLUSION: ROOT CAUSE RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: IT IS UNCERTAIN WHETHER THE DEFECT OBSERVED ON UNIT 2 WAS CAUSED BY MANIPULATION OF THE DEVICE PRIOR TO INSERTION OR AFTER INSERTION. THE ROUGH EDGES ON THE SEPARATED PIECES OF TUBING ARE AN INDICATION OF TENSILE STRESS ON THE CATHETER TUBING. ACCORDING TO THE CUSTOMER STATEMENT ¿THEY MOVED THE 1ST NEEDLE TO THE FRONT AND THE REAR¿ WHICH COULD HAVE CONTRIBUTED TO THE FAILURE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 WHEN THE ANESTHESIOLOGIST TRIED TO PUNCTURE AN A-LINE WITH THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER, THE CATHETER WOULD NOT THREAD PROPERLY. WHEN INSERTING A SECOND CATHETER THE FIRST CATHETER WAS CUT AND BROKE THE TIP OFF INTO THE PATIENT¿S BODY. THE PATIENT NEEDED AN OPE TO HAVE THE PIECE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910937 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other