MAUDE Adverse Event Report: CARDINAL HEALTH POLYUR FEED TUBE 6.5FR X 20; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461420
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the end of the feeding tube (where the syringe attaches) came off of the tube when the rn was removing the tube from the infant.Per additional information received on (b)(6) 2022, there was no medical intervention required.And there was no injury reported.They had the tube replaced.The entire device was retrieved, no pieces were left in the patient.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
One sample with unknown lot number was received for evaluation.After performing a visual inspection, the separation of the purple connector was observed.The device history record review could not be performed since no lot number was provided from customer complaint report.A gemba walk was carried out with the multifunctional team on the production line.It was determined that the detachment of the purple connector was due to the lack of solvent.An improvement opportunity was detected to update the standard work instruction to prevent the reoccurrence of the reported condition.No further actions are required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: POLYUR FEED TUBE 6.5FR X 20
• 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: 15214069
• Report Number: 9612030-2022-03350
• Device Sequence Number: 11289852
• Product Code: KNT
• UDI-Device Identifier: 10884521067936
• UDI-Public: 10884521067936
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 461420
• Device Catalogue Number: 461420
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/15/2022
• 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