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

Model Number	8884721088E
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: the nurse met resistance right after the nasal passage, and pulled the tube back out and then realized the weights were no longer there.The patient was not injured.A kidney, ureter and bladder (kub) xray was ordered and obtained after escalating to the physician.The kub indicated the weights were in the small intestine.The physician ordered another kub for the morning and there was no change in the location of the weights.The patient is currently being monitored closely without any surgical intervention.Per additional information received on 06/06/24, the tube was replaced and removed as soon as the nurse realized the weights were missing off the end.There were no additional interventions required.The patient is stable and doing well.He has been downgraded to intermediate care.It is unknown if the patient has passed the weights in their stool at this time.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that the device history record for each lot affected was reviewed and showed that manufacturing and inspection product was performed as per applicable procedures and validated process.All inspection results were within acceptable criteria as per established sampling plan levels quality procedures.One product sample received for evaluation.The sample was visually inspected based on product specifications.The sample arrived in its original package, and without the bolus, which is connected to the adapter.The root cause and action plan will be documented through a formal corrective/preventative action which has been initiated to address the reported condition to mitigate any further occurrences.All information received will be used for further tracking and trending purposes.

• Brand Name: ENTRFLX 10FR 43IN W STY YPORT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; mansfield MA 02048
• 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: 19490857
• Report Number: 9612030-2024-00084
• Device Sequence Number: 17933389
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 8884721088E
• Device Catalogue Number: 8884721088E
• Device Lot Number: 2302408764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/14/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown