BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 6774147 · Received August 8, 2017

    Report

    Report Number
    3003916417-2017-00022
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    June 26, 2017
    Report Date
    January 9, 2018
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FOZ
    PMA / PMN Number
    K950301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DESCRIBE EVENT OR PROBLEM AND THE MEDICAL DEVICE BRAND NAME FIELDS HAVE BEEN UPDATED TO REFLECT THE CORRECTED DEVICE NAME BD ANGIOCATH¿ IV CATHETER.

    Additional Manufacturer Narrative · 1

    CORRECTION: INCORRECT MEDICAL DEVICE BRAND NAME FILED IN INITIAL AND SUPPLEMENTAL MDRS. THE BELOW FIELDS WERE CORRECTED AND UPDATED TO THE FOLLOWING: MEDICAL DEVICE BRAND NAME: BD ANGIOCATH¿ IV CATHETER 22 G X 1". PMA / 510(K)#: K950301.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY SAMPLES/ PHOTOS: SAMPLES OR PHOTOS HAVE NOT RECEIVED FOR ANALYSIS OF THE INCIDENT IN QUESTION. RETAIN SAMPLE EVALUATION: NOT APPLY. DHR REVIEW: THE FINAL ASSEMBLY LOT: 6267332 USED IN THE FINAL PRODUCT LOT: 6270056 OF ANGIOCATH 22G WAS ANALYZED FOR THE TESTS PERFORMED FOR FOREIGN MATTER AND NO RECORDS WERE FOUND THAT COULD CLEARLY LEAD TO THE DEFECT CLAIMED. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NON-CONFORMITY REPORT RECORDS OF FOREIGN MATTER FOR THE LOTS INVOLVED IN THIS COMPLAINT, ACCORDING TO THE HISTORY OF THE LOT ABOVE. INVESTIGATION CONCLUSION: SAMPLES/ PHOTOS: SAMPLES OR PHOTOS HAVE NOT RECEIVED FOR ANALYSIS OF THE INCIDENT IN QUESTION. RETAIN SAMPLE EVALUATION: NOT APPLY. DHR REVIEW: THE FINAL ASSEMBLY LOT: 6267332 USED IN THE FINAL PRODUCT LOT: 6270056 OF ANGIOCATH 22G WAS ANALYZED FOR THE TESTS PERFORMED FOR FOREIGN MATTER AND NO RECORDS WERE FOUND THAT COULD CLEARLY LEAD TO THE DEFECT CLAIMED. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NON-CONFORMITY REPORT RECORDS OF FOREIGN MATTER FOR THE LOTS INVOLVED IN THIS COMPLAINT, ACCORDING TO THE HISTORY OF THE LOT ABOVE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION RESULTS TO DATE THE ROOT CAUSE WAS NOT FOUND FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    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

    A CONSUMER REPORTED WHITE RESIDUE WAS FOUND IN A BD ANGIOCATH¿ IV CATHETER PRIOR TO USE. NO INJURY OR MEDICAL INTERVENTIONS WERE REPORTED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED WHITE RESIDUE WAS FOUND IN A BD ANGIOCATH¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA X 1.00IN 0.9 X 25MM PRIOR TO USE. NO INJURY OR MEDICAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553267 BD ANGIOCATH¿ IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON IND. CIRURGICAS LTDA 6270056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other