MAUDE Adverse Event Report: COVIDIEN ENTFLX 12FR;43IN W/STYL YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721252

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2020

Event Type  malfunction  

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 Description

The customer reported that an attempt to pass an ng tube was unsuccessful because when removing the guide wire, it was dented, elbowing the tube.

Manufacturer Narrative

The incident sample was received for evaluation.Upon receipt, the sample was determined to be product number 8884721252, not 8884711253 as originally reported.The initial reporter confirmed that 8884721252 is the correct product involved in this incident.An updated investigation is currently underway.Upon completion, the results will be forwarded.D1 brand name; d4 model number; d4 catalog number, d4 unique identifier (udi) #; d9 device returned to manufacturer; d9 date device returned to manufacturer; h3 device evaluated by manufacturer.

Manufacturer Narrative

H3 evaluation summary: the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated entriflex tube without the original package or lot number was received at the manufacturing plant for evaluation.The hydromer was activated in the sample and the stylet was removed.The condition reported was confirmed because the stylet was observed to be bent; however, during duplication trials, this condition could not be replicate per the manufacturing process.Because this condition was reported after use, a possible root cause could be damage caused during use.The material met specifications when produced in the plant.During the investigation with the multidisciplinary team, a walkthrough was performed of the manufacturing process.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.The reported condition could not be confirmed as manufacturing related.No action plan is deemed required.The current process is running according to product specifications, meeting quality acceptance criteria.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTFLX 12FR;43IN W/STYL YPORT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10870770
• MDR Text Key: 217325780
• Report Number: 9612030-2020-02697
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2021

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
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 1920404064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 11/10/2020; 11/10/2020
• Supplement Dates FDA Received: 09/30/2021; 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1