MAUDE Adverse Event Report: COVIDIEN PED-TBE 6FR;20IN WGT W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884730741
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2020
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 there were perforations in the tube and leaking was observed through the y port of the feeding tube during use.There was no patient injury.
Additional Manufacturer Narrative
A review of the device history record revealed no discrepancies that may have contributed to the reported condition.All quality assurance testing is performed during the manufacturing of the product met specification requirements.A photograph was submitted for evaluation, however based on the digital image it is not possible to confirm the reported condition.The physical sample is needed to assess the reported condition and thus determine the root cause.A potential root cause for leaking which can occur during use if there are any deviations to the instruction for use which state: ¿for the insertion and use of the of the feed tube and extraction of the stylet for stylet placement; using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating.¿ the reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: PED-TBE 6FR;20IN WGT W/STYLET
• 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: 9866595
• Report Number: 9612030-2020-02438
• Device Sequence Number: 10894206
• Product Code: KNT
• UDI-Device Identifier: 30884521009619
• UDI-Public: 30884521009619
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/29/2020

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: 8884730741
• Device Catalogue Number: 8884730741
• Device Lot Number: 1812284464
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/29/2020
• Patient Sequence Number: 1