BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ 24G X 0.75IN (0.7 X 19 MM)

    MDR report key: 6852255 · Received September 8, 2017

    Report

    Report Number
    1710034-2017-00178
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    August 14, 2017
    Report Date
    August 22, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INVESTIGATION: DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 5173560 ¿ THE LOT WAS BUILT ON (B)(4), FROM JUNE 25, 2015 THRU JUNE 29, 2015. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION S-AU8 IN ACCORDANCE WITH THE SET ¿UP AND 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. THE LOT WAS PACKAGED ON PACKAGING (B)(4), FROM JULY 15, 2015 THRU JULY 17, 2015. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION S-AU8 IN ACCORDANCE WITH THE SET ¿UP AND 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. 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: RECEIVED ONE UNUSED IAG 24GA UNIT IN A SEALED PACKAGE FROM THE LOT NUMBER 5173560. VISUAL/MICROSCOPIC EXAMINATION: OBSERVED THERE WAS A HAIR, WHICH WAS APPROXIMATELY 1 INCH IN LENGTH, NEAR THE SAFETY BARREL INSIDE OF THE SEALED PACKAGE. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO, THE RETURNED UNIT PROVIDED FOR EVALUATION DISPLACED A STRAND OF HAIR IN THE SEALED PACKAGE. CONCLUSIONS: THE DEFECT OF FOREIGN MATTER, AS STATED IN THE SUBJECT OF THE PIR WAS CONFIRMED WITH THE OBSERVED PIECE OF HAIR IN THE SEALED PACKAGE. THE FOREIGN MATTER (HAIR) WAS INTRODUCED DURING THE ASSEMBLY OR PACKAGING PROCESS. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? YES; THE CUSTOMER EXPERIENCE WAS CONFIRMED BASED ON THE EVALUATION THAT WAS PERFORMED ON THE RETURNED UNIT. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: MANUFACTURING ASSEMBLY/PACKAGING PROCESS COMMENT: POTENTIAL CAUSES INCLUDE VIOLATIONS OF THE GMPS INCLUDING QS3-0035, WHICH DEFINES THE BD GOWNING POLICY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE A BD INSYTE¿ AUTOGUARD¿ 24G X 0.75 IN (0.7 X 19 MM). INJURY AND MEDICAL INTERVENTION ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633102 BD INSYTE¿ AUTOGUARD¿ 24G X 0.75IN (0.7 X 19 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5173560

    Patients

    Seq Age Sex Outcome Treatment
    1 Other