FDA Adverse Event Injury Summary report: N

CATHETER

MDR report key: 2871523 · Received December 6, 2012

Report

Report Number: 2026095-2012-00301
Event Type: Injury
Date Received: December 6, 2012
Date of Event: November 6, 2012
Report Date: November 6, 2012
Manufacturer: I-FLOW, LLC
Product Code: BSO
PMA / PMN Number: UNK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

METHOD: THE SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. CONCLUSION: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE. SURGEON: (B)(6).

Description of Event or Problem · 1

DRUG/DILUENT: MARCAINE. FILL VOLUME: UNK. FLOW RATE: UNK. PROCEDURE: ABDOMINOPLASTY. CATHPLACE: ABDOMINAL FASCIA. THE OPERATING ROOM NURSE CALLED THE I-FLOW NURSE HOTLINE TO ASK IF THE CATHETER WAS RADIO OPAQUE AND STATED THAT THE CATHETER HAD BEEN STRETCHED. THE DOCTOR HAD BROKEN A CATHETER. THE DOCTOR REPORTED THAT WHEN HE PULLED THE CATHETER OUT IT WAS MISSING AN ESTIMATED 4CM SECTION. DOCTOR FEELS THE MISSING SECTION IS IN A BENIGN SECTION OF THE ABDOMINAL FASCIA. THE DOCTOR STATED THAT THE PATIENT WILL BE RETURNING FOR ANOTHER PROCEDURE IN 2-3 MONTHS AND HE PLANS TO REMOVE THE SECTION OF CATHETER DURING THAT TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CATHETER	CATHETER	BSO	I-FLOW, LLC	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	40 YR		Other