FDA Adverse Event Malfunction Summary report: N

NEOMED POLYURETHANE FEEDING TUBE

MDR report key: 2483356 · Received February 20, 2012

Report

Report Number: 3006520777-2012-00001
Event Type: Malfunction
Date Received: February 20, 2012
Date of Event: December 19, 2011
Report Date: February 28, 2012
Manufacturer: NEOMED INC.
Product Code: FPD
PMA / PMN Number: K082238
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A VISUAL EXAM OF THE RECOVERED BROKEN TIP UNDER MAGNIFICATION REVEALED A DEFINITIVE SAW-TOOTHED PATTERN WHERE THE TIP WAS DETACHED, STRONGLY SUGGESTING A MECHANISM INVOLVING EXTERNAL TRAUMA SUCH AS CROSS-CLAMPING WITH A HEMOSTAT WITH SERRATED JAWS AT THE DISTAL SIDE HOLE LOCATED AT APPROX 1.5 CM FROM THE TIP. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. THE INSTRUCTIONS FOR USE STATES "POLYURETHANE FEEDING TUBES ARE FRAGILE AND MUST BE HANDLED WITH CARE. FORCEPS, CLAMPS, AND SHARP INSTRUMENTS CAN DAMAGE POLYURETHANE FEEDING TUBES." A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE COMPLAINANT DID NOT PROVIDE A LOT NUMBER.

Description of Event or Problem · 1

CUSTOMER SUBMITTED MEDWATCH FORM TO FDA TO REPORT A BROKEN FEEDING TUBE TIP IN THE PT WHILE THE TUBE WAS INDWELLING. THE BROKEN TIP DID NOT APPEAR TO MIGRATE THROUGH THE GUT. AS A RESULT OF AN RELATED DISEASE PROCESS, THE PT HAD SURGERY EARLIER IN THE MONTH TO REMOVE NECROTIC BOWEL. THE CUSTOMER NOTED THAT THE CAUSE OF THE NECROTIC BOWEL WAS UNRELATED TO THE FEEDING TUBE TIP. THE FEEDING TUBE TIP WAS RECOVERED DURING THAT SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEOMED POLYURETHANE FEEDING TUBE	TUBE, FEEDING (POLYURETHANE)	FPD	NEOMED INC.	FTM6.5P-EO	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	22 YR