MAUDE Adverse Event Report: CARDINAL HEALTH POLYUR F T 6.5FRX20IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461420E

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.

Event Description

Customer reports: two of the ng tubes were defective.They were coiling & kinking up at the end and wouldn¿t stay straight.

Manufacturer Narrative

Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.If more information is received at a later date, the investigation will be reopened, and the investigation will be updated accordingly.

• Brand Name: POLYUR F T 6.5FRX20IN W ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 17330258
• MDR Text Key: 319673402
• Report Number: 9612030-2023-03764
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521547131
• UDI-Public: 10884521547131
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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: 461420E
• Device Catalogue Number: 461420E
• Device Lot Number: 2309515364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1