FDA Adverse Event Injury Summary report: N

TUBE, GASTROINTESTINAL (AND ACCESS)

MDR report key: 1971492 · Received January 21, 2011

Report

Report Number: 3006260740-2011-00025
Event Type: Injury
Date Received: January 21, 2011
Date of Event: December 23, 2010
Report Date: January 6, 2011
Manufacturer: C. R. BARD INC. (BASD)
Product Code: KNT
PMA / PMN Number: K915837
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT OF A BREAK IN THE RETENTION DOME IS CONFIRMED AND WILL BE REPORTED AS USER RELATED. UPON RECEIPT, A PARTIAL SEMI-CIRCULAR BREAK IN THE RETENTION DOME WAS OBSERVED. A SMALL SECTION OF THE BROKEN DOME IS STILL ATTACHED TO THE FEEDING TUBE AND REVEALS A COMPLETE BOND. THE BROKEN SECTION OF THE RETENTION DOME WAS NOT RETURNED FOR EVAL. THE DULL AND ROUNDED VENEER IDENTIFIED AT THE DOME SITE ARE TRAITS THAT ARE INDICATIVE OF EXCESSIVE FORCE THAT WAS APPLIED DURING THE REMOVAL OF THIS DEVICE. THE LACK OF ANY ASSOCIATED DAMAGE SUGGESTS THE TEAR IN THE DOME WAS CAUSED BY STRETCHING THE DOME MATERIAL BEYOND ITS ELASTIC LIMITS DURING REMOVAL. THE COMPLAINANT INDICATES THE COMPLAINT SAMPLE HAD BEEN IN PLACE FOR APPROX 122 DAYS PRIOR TO THE COMPLAINT INCIDENT. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS SHOW NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MFG PROCESS. A CHR IS NOT POSSIBLE AS NO MFG LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.

Description of Event or Problem · 1

A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELL TIME WAS 122 DAYS. THE DOME PORTION WAS REMOVED WITH AN ENDOSCOPE. NO OBVIOUS PHYSICAL CHARACTERISTICS CONTRIBUTING TO THIS TYPE OF INCIDENT WAS NOTED ON THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TUBE, GASTROINTESTINAL (AND ACCESS)		KNT	C. R. BARD INC. (BASD)		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention