MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR;43IN W/STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721088
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
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 the guide wire of the nasojejunal tube was tested for removal, but there was difficulty in carrying out this action.The guide did not come out of the tube so insertion was not performed.
Additional Manufacturer Narrative
Additional information h2, h3, h6.Investigation conclusion the customer reported the nasojejunal tube was uncovered and the exit of the guide was tested, but there was difficulty in carrying out this action.The guide does not come out so insertion was not performed.The report for product 8884721088, entrflx 10fr 43in w/sty yport, with lot number 2028762864 was investigated.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 defect from customer complaint.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Lot and failure mode trending was reviewed, and no related adverse trends were identified.The reported product was discarded and thus not returned for evaluation; however, a photograph was provided.Visual inspection of the photograph was unable to confirm the reported product failure.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.The most likely root cause indicates that this issue could occur due to the inadequate use of the procedure if the instructions for use are not followed.A failure to activate the hydromer makes difficult to remove the stylet from the feeding tube.Please refer to the ifu instructions for the proper procedure for insertion of the feed tube and extraction of the stylet: "using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating".Additional action will not be taken at this time.This complaint will be used for monitoring and trending purposes.

• Brand Name: ENTRFLX 10FR;43IN W/STY YPORT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; 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: 12861610
• Report Number: 9612030-2021-03098
• Device Sequence Number: 4265960
• Product Code: KNT
• UDI-Device Identifier: 10884521518872
• UDI-Public: 10884521518872
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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: 8884721088
• Device Catalogue Number: 8884721088
• Device Lot Number: 2028762864
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male