MAUDE Adverse Event Report: CARDINAL HEALTH CONT. FEEDING SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884741821
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
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 nurse reported that the item is broken where it connects to the pump.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed since no lot number was provided from customer complaint report.A sample analysis was not possible as there was no photographs or samples provided for evaluation.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).If a sample should be returned, this complaint will be reopened, and the investigation updated to reflect our findings.Since this complaint will be considered unconfirmed, no corrective or preventive actions will be taken at this time.

• Brand Name: CONT. FEEDING SET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; 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: 16195588
• Report Number: 9612030-2023-03526
• Device Sequence Number: 20282256
• Product Code: KNT
• UDI-Device Identifier: 30884521011650
• UDI-Public: 30884521011650
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 02/16/2023

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: 8884741821
• Device Catalogue Number: 8884741821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/16/2023
• 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