MAUDE Adverse Event Report: COVIDIEN 12FR 55 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461255E

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reports the kangaroo tube cracked in 2-3 different places at the connection ports, and leaked when the fluid was being infused.There was no harm to the patient.

Manufacturer Narrative

H 3 evaluation summary.The device history record (dhr) could not be reviewed because the lot number was not provided.A sample has been returned for investigation.The tube is unsealed, and the stylet has been pulled out of the tube.This is a supplied product.According to the supplier, all products are tested and inspected and have met the specified requirements prior to being released for shipment.The packing process was reviewed.The tube from the supplier has the y-port assembly on the tube before packing at the site.Any broken y-port issues can be detected by inspectors on the production line.The manufacturing process was reviewed, all the tubes go through leak testing before packing.Any leaking issue would be detected at the leak test station.From the investigation, the root cause could not be determined.There is no action taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 12FR 55 IRIS FEEDING TUBE ENF
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8789592
• MDR Text Key: 151272930
• Report Number: 1282497-2019-08560
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 20884521742236
• UDI-Public: 20884521742236
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461255E
• Device Catalogue Number: 461255E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 03/02/2020
• Patient Sequence Number: 1