MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TUBE,GASTROSTOMY,20FR,3-PORT,WHITE,1/BX

Catalog Number DYND70320

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/30/2023

Event Type  Injury  

Event Description

According to the customer, the tube is "easily tearing apart" and "leaks on the port".

Manufacturer Narrative

According to the customer, the tube is "easily tearing apart" and "leaks on the port".The customer reported the product has been replaced as a result.No additional information is available at this time.Sample requested for return evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: TUBE,GASTROSTOMY,20FR,3-PORT,WHITE,1/BX
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18233671
• MDR Text Key: 329315188
• Report Number: 1417592-2023-00473
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10080196837922
• UDI-Public: 10080196837922
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYND70320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other