MAUDE Adverse Event Report: COVIDIEN 12FR ENDO TB FOR ENDOSCPIC PLC; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884752505
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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 a (b)(6) year old female patient was referred by her attending physician for jaundice associated with altered general condition with anorexia for 1 week.During an echo-endoscopy, a naso-jejunal probe was placed.During the installation, it was impossible to get the guide out through the end of the naso-jejunal probe.No exit port.Consequences were a longer examination time and a change of device.There was no harm to the patient.
Additional 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 sample was received for evaluation at the manufacturing site.The sample was reviewed, and the reported condition could not be detected.The sample was received without the guide and the reported issue could not be reproduced.During the investigation, a review through the manufacturing process was conducted.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 most likely root cause indicates that this issue could occur due to a failure to activate the hydromer making it difficult to remove the stylet from the feeding tube.The instructions for use state to rinse the feeding tube with 20 ml of water and advance the tip of the probe onto the guide.With the guide coming out of the proximal end of the probe, grab and keep the guide taut while inserting the probe to the desired depth under fluoroscopic control.No action plan is deemed required since the reported condition could not be confirmed.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: 12FR ENDO TB FOR ENDOSCPIC PLC
• Common Device Name: 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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12217514
• Report Number: 9612030-2021-03001
• Device Sequence Number: 3723692
• Product Code: KNT
• UDI-Device Identifier: 10884521519022
• UDI-Public: 10884521519022
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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: 8884752505
• Device Catalogue Number: 8884752505
• Device Lot Number: 2029302564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female