MAUDE Adverse Event Report: CARDINAL HEALTH 10FR X 55 ENTRIFLEX W/STYLET; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	8884721055E
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported while in the or, the tube was placed by hand.The stylet was not able to be retracted.The tube was flushed again and still it would not retract.Additional force was applied and the cap torn off leaving exposed wire.There was no option but to remove the tube and replace it.No injury.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One sample without original packaging was received for evaluation.The sample was visually inspected per procedure.The reported issue was confirmed; the hub was disassembled from the wire (stylet).During the evaluation of the returned device, the hydromer was activated and the stylet was removed without resistance.The most likely root cause for the reported issue is due to inadequate use of the procedure if the instructions for use were not followed correctly such as a failure to activate the hydromer which makes it difficult to remove the stylet from the feeding tube resulting in a hub detachment.The instructions for use (ifu) for the proper procedure for insertion of the feeding tube and extraction of the stylet state "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.This complaint will be used for tracking and trending purposes.

• Brand Name: 10FR X 55 ENTRIFLEX W/STYLET
• Common Device Name: 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; 777 west st; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west st; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14112918
• Report Number: 9612030-2022-03220
• Device Sequence Number: 2122166
• Product Code: PIF
• UDI-Device Identifier: 10884521582989
• UDI-Public: 10884521582989
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: 8884721055E
• Device Catalogue Number: 8884721055E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown