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

Model Number	461255E
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8789592
• Report Number: 1282497-2019-08560
• Device Sequence Number: 14212911
• Product Code: PIF
• UDI-Device Identifier: 20884521742236
• UDI-Public: 20884521742236
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 461255E
• Device Catalogue Number: 461255E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 03/02/2020
• Patient Sequence Number: 1