MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC NASAL JEJUNAL FEEDING TUBE; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number	NJFT-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.However, a device failure was not reported, only procedural complications.Prior to distribution, all nasal jejunal feeding tube are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During an nasal jejunal placement procedure for duodopa use, the physician used a cook nasal jejunal feeding tube.It was reported [that the] patient was short of breath on return to ward post nj tube insertion.Clinical review attended with hospital medical officer.Chest/abdomen x ray attended for confirmation of tube placement with nj tube confirmed in duodenum/jejunum.Further investigations continued.Patient remained resting in bed with supplemental oxygen supply via nasal prongs and improved shortness of breath.Duodopa continued uninterrupted and without concern.Nj tube remains inside with patient continuing to be less breathless after medical intervention.No further information given.A section of the device did not remain inside the patient¿s body.The patient required oxygen supply via nasal prongs.According to the initial reporter, the patient experienced shortness of breath.

• Brand Name: NASAL JEJUNAL FEEDING TUBE
• Common Device Name: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 17690062
• Report Number: 1037905-2023-00416
• Device Sequence Number: 12276320
• Product Code: KNT
• UDI-Device Identifier: 10827002223018
• UDI-Public: (01)10827002223018(17)250208(10)W4563323
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2025
• Device Catalogue Number: NJFT-10
• Device Lot Number: W4563323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE - UNKNOWN MAKE AND MODEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male