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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY INC AMT MINI ONE 16F 2.0 CM GASTROSTOMY TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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APPLIED MEDICAL TECHNOLOGY INC AMT MINI ONE 16F 2.0 CM GASTROSTOMY TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2019
Event Type  malfunction  
Event Description
Patient's family presented to center for aids intervention research clinic with reports that they were unable to extract the water from the balloon port of his 16f 2.0cm amt gastrostomy tube.Port was gentle cleansed of visible debris and multiple attempts were made by providers to deflate the gastric tube balloon without success.The infusion element of the tube was without malfunction.Balloon valve of the tube was excised using trauma sheers and then water extracted using a syringe and 22-gauge needle.Balloon valve became non-functional disallowing extraction of the water in the balloon and thus removal of the gtube.
 
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Brand Name
AMT MINI ONE 16F 2.0 CM GASTROSTOMY TUBE
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
APPLIED MEDICAL TECHNOLOGY INC
8006 katherine boulevard
brecksville OH 44141
MDR Report Key9290214
MDR Text Key165472165
Report Number9290214
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/01/2019
Date Report to Manufacturer11/07/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age2920 DA
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