MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TUBE,GASTROSTOMY,16FR,3-PORT,WHITE,1/BX

Catalog Number DYND70316

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the gastrostomy tube's balloons were deflating resulting in the gastrostomy tubes falling out from the patients.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural/event details.The number of events or patients involved was not reported.Due to the reported incident and in an abundance of caution, this medwatch is being filed.Companion samples were returned for evaluation and the reported issue could not be confirmed.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the gastrostomy tube's balloons were deflating resulting in the gastrostomy tubes falling out from the patients.

• Type of Device: TUBE,GASTROSTOMY,16FR,3-PORT,WHITE,1/BX
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8424332
• MDR Text Key: 139078136
• Report Number: 1417592-2019-00033
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10080196837892
• UDI-Public: 10080196837892
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND70316
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other