MAUDE Adverse Event Report: COVIDIEN GSTRO FEED TBE W/Y PRT 14FR EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884715148E
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
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 the tube was punctured.There was no patient harm reported.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One decontaminated sample was received for the evaluation.Upon functional evaluation, the balloon was inflated with 5ml of air and the balloon remains inflated for more than 10 minutes.Therefore, the reported condition is not confirmed.No action plan is deemed required at this time.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: GSTRO FEED TBE W/Y PRT 14FR EN
• 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: 11067207
• Report Number: 9612030-2020-02730
• Device Sequence Number: 14093275
• Product Code: KNT
• UDI-Device Identifier: 10884521007222
• UDI-Public: 10884521007222
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/25/2021

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: 8884715148E
• Device Catalogue Number: 8884715148E
• Device Lot Number: 1912741964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/25/2021
• Patient Sequence Number: 1