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

Model Number	8884720858E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on november 07, 2023.A physical sample was not received for the investigation, but two photos were provided.The photos were reviewed, and the rupture of the tube was confirmed.Based on all available information, a definitive root cause could not be determined.A corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.If a sample is received at a later date, the investigation will be updated accordingly.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported the entriflex feeding tube was blocked.It was successfully unblocked as per hospital policy.The patient coughed out the entriflex tube.Upon inspection of the tube, the end of the tube was shattered.Tip of tube - 17cm was missing.Abdominal x-ray confirmed part of the tube was retained in the patient.Per additional information provided by the customer on 25jul2024, as of today the retained portion of the feeding tube is still in the patient's stomach, confirmed by x-ray.No procedure has been done yet to remove it.Actions being done: daily abdominal x-ray to monitor location of the retained feeding tube, monitor patient for possible bowel obstruction or perforation and pain, monitor bowel movement to check if the retained tube had been passed out.If not passed out, plan for possible endoscopic removal of the retained tube by a gastroenterologist specialist.Patient is for discharge home today.Plan for outpatient follow up with the gastroenterologist.No new feeding tube has been inserted.No actual harm to the patient at the moment.Patient is stable.Per further information provided on 13aug2024, because the customer was discharged from their unit with the retained tube and a plan for follow-up with a gastroenterologist, they do not have any further updates.They do no have any follow-up information as he is no longer an inpatient.

• Brand Name: ENTRFLX 8FR 43INW STYLTY SITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19977387
• Report Number: 1423537-2024-00108
• Device Sequence Number: 7048165
• Product Code: KNT
• UDI-Device Identifier: 10884521582972
• UDI-Public: (01)10884521582972(17)281031(10)2330600564
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K833621
• 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
• Report Date (Section B): 08/13/2024

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: 8884720858E
• Device Catalogue Number: 8884720858E
• Device Lot Number: 2330600564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/13/2024
• Date Device Manufactured: 11/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male