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

Catalog Number	DYND70316
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that an unknown number of incidents occurred wherein gastrostomy tubes were coming out from patients.A patient reportedly had to be sent to the hospital to have a new gastrostomy tube put in.Saline was used to inflate the gastrostomy tubes' balloons and the balloons were reportedly inflated as indicated.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.Due to the reported medical intervention to replace the gastrostomy tube, this medwatch is being filed.A companion sample was returned for evaluation.A definitive root cause could not be identified at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that an unknown number of incidents occurred wherein gastrostomy tubes were coming out from patients.A patient reportedly had to be sent to the hospital to have a new gastrostomy tube put in.

• Common Device Name: TUBE,GASTROSTOMY,16FR,3-PORT,WHITE,1/BX
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8603624
• Report Number: 1417592-2019-00070
• Device Sequence Number: 2000029
• Product Code: KNT
• UDI-Device Identifier: 10080196837892
• UDI-Public: 10080196837892
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYND70316
• Device Lot Number: S18009002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention