FDA Adverse Event Malfunction Summary report: N

MAGIC 3 FEMALE INTERMITTENT CATHETER

MDR report key: 4801965 · Received May 27, 2015

Report

Report Number: 1018233-2015-15067
Event Type: Malfunction
Date Received: May 27, 2015
Report Date: May 27, 2015
Manufacturer: ROCHESTER MEDICAL CORP.
Product Code: KOD
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS MEDWATCH IS NOT ASSOCIATED WITH A REPORTED ADVERSE EVENT, HOWEVER IT IS BEING FILED IN ACCORDANCE WITH 21 CFR 803.53. THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PTS REQUIRING CATHETERIZATION, INCLUDING SELF-CATHETERIZATION, FOR MANAGEMENT OF INCONSISTENCE, VOIDING DYSFUNCTION, OR SURGICAL PROCEDURES AS A RESULT OF PREEXISTING OR ACUTE CONDITIONS SUCH AS SPINA BIFIDA, SPINAL TRAUMA, OR OTHERS. USE OF NON-STERILE MAGIC3 HYDROPHILIC-COATED FEMALE INTERMITTENT CATHETERS COULD INTRODUCE MICROORGANISMS TO THE URINARY TRACT DURING A CATHETERIZATION PROCEDURE WHICH MAY LEAD TO A VARYING DEGREE OF RISK INCLUDING LOCALIZE AND/OR SYSTEMIC INFECTIOUS COMPLICATIONS RANGING FROM URINARY TRACT INFECTION TO UROSEPSIS. IN THE EVENT THIS OCCURRED, THE PT MAY REQUIRE MEDICAL INTERVENTION. THIS REPORT APPLIES TO: PRODUCT CODE 51614 - MAGIC 3 HYDROPHILIC-COATED FEMALE INTERMITTENT CATHETERS 14 FR. LOT NUMBER 73600123. ALL INVESTIGATIONS WILL BE LINKED TO INVESTIGATION NUMBER (B)(4).

Description of Event or Problem · 1

BARD MEDICAL (BMD) HAS CONFIRMED THAT AN EVENT OCCURRED INVOLVING 45 LOTS OF 5 PRODUCT CODES. AS A RESULT, THESE PRODUCTS ARE AT RISK FOR HAVING A SMALL VOID IN THE PACKAGE SEAL AND PRODUCT STERILITY MAY BE AFFECTED. FORTY-TWO OF THESE LOTS WERE SHIPPED TO CUSTOMERS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
344193	MAGIC 3 FEMALE INTERMITTENT CATHETER	FEMALE INTERMITTENT CATHETER	KOD	ROCHESTER MEDICAL CORP.	NA	73600123

Patients

Seq	Age	Sex	Outcome	Treatment
1