FDA Adverse Event Injury Summary report: N

EPIDURAL CATHETERIZATION KIT

MDR report key: 2469326 · Received December 22, 2011

Report

Report Number: 1036844-2011-00431
Event Type: Injury
Date Received: December 22, 2011
Date of Event: November 11, 2011
Report Date: December 21, 2011
Manufacturer: ARROW INTL., INC.
Product Code: CAZ
PMA / PMN Number: K884552
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE. ADDITIONAL INFO FROM THE USER FACILITY REPORT: DEVICE NAME: ARROW INTL., INC. COMMON DEVICE NAME: FLEXTIP PLUS CATHETER. (B)(6).

Description of Event or Problem · 1

INFO WAS RECEIVED VIA MEDWATCH REPORT. IT WAS REPORTED THE EVENT OCCURRED DURING EPIDURAL PLACEMENT IN THE LABOR AND DELIVERY AREA, ON A (B)(6) FEMALE WEIGHING (B)(6) KGS. THE CATHETER BROKE OFF WHILE IT WAS BEING ADJUSTED. ENTRY INTO EPIDURAL SITE WAS UNCOMPLICATED, AS WAS CATHETER INSERTION. HOWEVER, UPON ADJUSTING THE LENGTH OF THE CATHETER, THE CATHETER BROKE OFF. VERY SMALL (REINFORCING WIRE THAT COMPOSES PART OF THE EPIDURAL CATHETER) WIRE REMAINED AT ENTRY SITE PROTRUDING OUT OF THE SKIN APPROX 4-5 CM. UPON CAREFUL EXAMINATION OF THE ENTRY SITE, THE PLASTIC PART OF THE EPIDURAL WAS NOT VISIBLE. UPON EXAM OF THE REMAINING CATHETER, APPROX 5CM OF THE CATHETER HAS BEEN BROKEN OFF AND IS IN THE EPIDURAL SPACE WITH SOME PORTION POSSIBLY IN THE SPACE BETWEEN THE SKIN TO NEEDLE'S ENTRY SITE. PT WAS TAKEN TO THE OPERATING ROOM FOR RETRIEVAL OF THE CATHETER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EPIDURAL CATHETERIZATION KIT	ANESTHESIA PRODUCTS	CAZ	ARROW INTL., INC.	AK 05503	RF1093962

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR		Required Intervention