BEUDAMED
    FDA Adverse Event Other Summary report: N

    REMINGTON MEDICAL

    MDR report key: 3452861 · Received October 25, 2013

    Report

    Report Number
    1056553-2013-00001
    Event Type
    Other
    Date Received
    October 25, 2013
    Report Date
    October 24, 2013
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    KNW
    PMA / PMN Number
    K982401
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    E. COIL IS A VERY COMMON BACTERIA IN HUMAN GASTROINTESTINAL SYSTEMS, AND SINCE PROSTATE BIOPSIES ARE CONDUCTED VIA RECTAL ACCESS, THIS TYPE OF INFECTION IS POSSIBLE. THIS IS A RISK INHERENT TO THIS TYPE OF PROCEDURE.

    Description of Event or Problem · 1

    A PHYSICIAN HAD BEEN PROVIDED THREE (3) REMINGTON MEDICAL NAC-1825B BIOPSY NEEDLES TO TRY OUT ON PROSTATE BIOPSY PROCEDURES. AFTER USE, THE PHYSICIAN CONTACTED REMINGTON MEDICAL VIA E-MAIL ON (B)(6) 2013 AND REPORTED: "2 PTS BECAME SEPTIC DESPITE TREATING THEM ALL THE SAME WAY I DID 12 BXS ALL DID WELL BUT THESE TWO." REMINGTON MEDICAL REQUESTED CLARIFICATION SINCE THE STATEMENT APPEARED TO SUGGEST THAT THE PHYSICIAN PERFORMED BIOPSIES ON TWELVE (12) PATIENTS WITH THESE NEEDLES, MEANING HE WOULD HAVE HAD TO USE THE SINGLE-USE NEEDLES ON MULTIPLE PATIENTS. HIS RESPONSE STATED: "BOTH PATIENTS (2) HAD 12 CORE BIOPSIES. BOTH HAD E. COLI UROSEPSIS DESPITE PROPHYLACTIC ANTIBIOTIC, PRE-OP AND PERI-OP ANTIBIOTICS." E. COLI IS A VERY COMMON BACTERIA IN HUMAN GASTROINTESTINAL SYSTEMS, AND SINCE PROSTATE BIOPSIES ARE CONDUCTED VIA RECTAL ACCESS, THIS TYPE OF INFECTION IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548464 REMINGTON MEDICAL AUTOMATIC CUTTING NEEDLE KNW REMINGTON MEDICAL, INC. NAC-1825B 130646

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSTRUMENT| REMINGTON MEDICAL CENTREFIRE 22 (CNF-22) BIOPSY