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

Model Number 8884721088

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Laceration(s) (1946)

Event Date 09/28/2021

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 the 10 fr gastric feeding tube was placed and after a nurse tried to pull the guide wire, the green cap on the end of the wire came off on the first pull.The wire itself would not dislodge from the tube even after putting fluid in the side port to activate the tube and using kelly clamp to pull the wire.The feeding tube had to be pulled out and replaced with another feeding tube.A different nurse placed the next feeding tube, the wire was checked prior to placing and was free.After placement again when wire was attempted to be removed, the green cap came off on the first pull (wire was barely pulled on) and the wire cut nurse's glove and finger.The wire was stuck, with much manipulation, pulling with kelly clamp, much water to side port to loosen wire, the wire was finally released.The nurse indicated that they have never had a wire cap come off before, and never had this difficulty with the wire coming out.Additional information was received from the customer and stated that the patient is an (b)(6) female.The nurse reported no injury to the patient involved other than an extra x-ray exposure.Per customer, minor treatment was provided for the wire cut on the nurse's finger includes nurse¿s finger was cleaned and bandaged by self.No follow up care required.

Manufacturer Narrative

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 issue reported.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The device was manufactured on october 21, 2020.One decontaminated sample without the original packaging or lot number was received at the manufacturing site for the investigation.A visual inspection was completed, and the hub detachment was confirmed.Upon a functional evaluation, the hydromer was activated, and the stylet was withdrawn without problem.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 of use are not followed.A failure to fully activate the hydromer with enough fluid can make it difficult to remove the stylet from the feeding tube.It is important to note that the instructions for use for the proper insertion procedure of the feeding tube and extraction of the stylet states ¿using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating".A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.We will continue to monitor the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 10FR;43IN W/STY YPORT
• Type of Device: 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: 12728162
• MDR Text Key: 279285872
• Report Number: 9612030-2021-03072
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518872
• UDI-Public: 10884521518872
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884721088
• Device Catalogue Number: 8884721088
• Device Lot Number: 2028702864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female