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

Model Number	8884730741
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	12/14/2020
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 progress was made when advancing the probe but when trying to remove the guide wire it got stuck and would not come out.It burst in half which required removal and the passage of a new probe.There were no injuries to the patient.
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.The device history record review showed during the production process, all acceptance criteria inspections were within acceptable limits per established sampling levels.During the investigation, a review through the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.One decontaminated sample with reported lot number was received for the analysis.Upon sample evaluation, the reported condition is not confirmed.The hydromer was activated and the stylet could be removed from the tube.The product worked properly, and no issues were found.The most likely root cause indicates that this issue could have occurred due to inadequate use of the procedure if the instructions of use are not followed.A failure to activate the hydromer makes difficult to remove the stylet from the feeding tube.Please refer to the instruction for use (ifu) directions for the proper procedure for insertion 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¿.No action plan is deemed required at this time, since the reported condition is identified as product misuse by the user.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa 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: 11078748
• Report Number: 9612030-2020-02731
• Device Sequence Number: 3261000
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 8884730741
• Device Catalogue Number: 8884730741
• Device Lot Number: 1812284464
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 03/18/2021
• Patient Sequence Number: 1
• Patient Age: 5 MO