MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 8FR 43INW STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884720858E

Device Problem Difficult to Remove (1528)

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

Event Date 07/06/2023

Event Type  malfunction  

Event Description

Customer reports: this incident was reported on 04/18/2023 by the endocrinology department of (b)(6) hospital.After installation of the probe, the guide is impossible to remove.After removal of the probe and guide assembly, the guide is still impossible to detach from the probe.A mobilization test of the guide had been carried out before installation.The offending device is not available at the pharmacy for expertise.We remain at your disposal for any further information.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.

Manufacturer Narrative

Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: ENTRFLX 8FR 43INW STYLTY SITE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; mansfield MA
• 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 ; 5086183740
• MDR Report Key: 17295647
• MDR Text Key: 318788819
• Report Number: 9612030-2023-03756
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: 10884521582972
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 2125602764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2023
• 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