MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR;43IN W/STY YPORT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884721088E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

The customer reported that the purple plastic cap came off exposing a sharp wire when the stylet was being pulled out.Additional information received on 16-feb-2022 stated that there were no injuries reported.The feeding tube did not need to be removed or replaced.The hydromer was activated prior to removing the stylet.

Manufacturer Narrative

A device history record review could not be performed because the affected lot number was not provided.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Unfortunately the sample has not yet been received for evaluation due to a customs delay while in transit.Once the sample is received, this complaint will be reopened for further investigation and the updated findings will be provided to you.Based on the current information available, we were unable to confirm the reported issue or determine the root cause, therefore 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.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

One sample was received for evaluation without the original packaging.The sample was visually inspected per our procedure and the reported issue was confirmed; the hub was disassembled from the wire.Because a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Based on the available information, the exact root cause could not be determined and is not expected to be related to the manufacturing process.Therefore 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.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 10FR;43IN W/STY YPORT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 13569672
• MDR Text Key: 285993676
• Report Number: 9612030-2022-03169
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884721088E
• Device Catalogue Number: 8884721088E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2022
• 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