MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 8FR X 42; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461800
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that they noticed a hole in the tube while inserting the feeding tube.
Additional Manufacturer Narrative
The device history record files were reviewed, and no discrepancy was found related to the reported condition.Two photographs were submitted for investigation and one decontaminated sample was received for analysis.After performing a visual inspection based on product specification; the tubing did appear ruptured caused by it being trapped within the seal of the package.The complaint has been confirmed.A formal corrective/preventative action has been initiated to further investigate and address the condition.

• Brand Name: POLYUR FEED TUBE 8FR X 42
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9201916
• Report Number: 9612030-2019-02322
• Device Sequence Number: 11549974
• Product Code: KNT
• UDI-Device Identifier: 10884521068018
• UDI-Public: 10884521068018
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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: 461800
• Device Catalogue Number: 461800
• Device Lot Number: 1920101064
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 01/02/2020
• Patient Sequence Number: 1