FDA Adverse Event Malfunction Summary report: N

MAGIC 3 FEMALE INTERMITTENT CATHETER

MDR report key: 4801984 · Received May 27, 2015

Report

Report Number: 1018233-2015-15079
Event Type: Malfunction
Date Received: May 27, 2015
Report Date: May 27, 2015
Manufacturer: ROCHESTER MEDICAL CORP.
Product Code: KOD
PMA / PMN Number: K000723
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE MEDWATCH IS NOT ASSOCIATED WITH A REPORTED ADVERSE EVENT, HOWEVER IT IS BEING FILED IN ACCORDANCE WITH 21CFR PART 803.53. THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PATIENTS REQUIRING CATHETERIZATION, INCLUDING SELF-CATHETERIZATION, FOR MANAGEMENT OF INCONTINENCE, 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 COMPLICATION RANGING FROM URINARY TRACT INFECTION TO UROSEPSIS. IN THE EVENT THIS OCCURRED, THE PATIENT MAY REQUIRE MEDICAL INTERVENTION. THIS REPORT APPLIES TO: PRODUCT CODE 51614- MAGIC 3 HYDROPHILIC - COATED FEMALE INTERMITTENT CATHETERS 14FR, LOT NUMBER 73600218. 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
343604	MAGIC 3 FEMALE INTERMITTENT CATHETER	FEMALE INTERMITTENT CATHETER	KOD	ROCHESTER MEDICAL CORP.	NA	73600218

Patients

Seq	Age	Sex	Outcome	Treatment
1