FDA Adverse Event Injury Summary report: N

PERIFIX CONTINUOUS EPIDURAL TRAYS

MDR report key: 3541674 · Received December 18, 2013

Report

Report Number: 2523676-2013-00409
Event Type: Injury
Date Received: December 18, 2013
Date of Event: December 3, 2013
Report Date: December 3, 2013
Manufacturer: B. BRAUN MEDICAL, INC.
Product Code: CAZ
PMA / PMN Number: K813186
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. WHILE NO SPECIFIC CONCLUSION CAN BE DRAWN, INCIDENTS OF THIS NATURE CAN OCCUR WHEN A CATHETER BECOMES LODGED BETWEEN RIGID BODY STRUCTURES AND IS STRETCHED BEYOND ITS DESIGN CAPABILITIES. IF THE SAMPLE IS REC'D FOR EVALUATION OR IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

Description of Event or Problem · 1

AS REPORTED BY THE USER FACILITY: REPORTS THE CATHETER WAS "FRAYED" UPON REMOVAL FROM THE PATIENT. NEUROSURGERY DID RETRIEVE THE CATHETER TIP. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
661033	PERIFIX CONTINUOUS EPIDURAL TRAYS	CONTINUOUS EPIDURAL TRAY W/ 17GA NEEDLE	CAZ	B. BRAUN MEDICAL, INC.	CE17TKFCS	0061331913

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other\| R