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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98432
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Internal Organ Perforation (1987); Device Embedded In Tissue or Plaque (3165)
Event Date 04/03/2020
Event Type  Injury  
Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer. A review of the device history record is not possible as a valid lot number was not provided. All information reasonably known as of 22 apr 2020 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by avanos medical inc. Represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc. Avanos medical inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).
 
Event Description
It was reported that after the successful initial placement procedure for a gastric-jejunal feeding tube, the patient experienced paint 6 days later. A ct scan was performed and showed a foreign body in the abdomen. Surgery was performed and the foreign body was determined to be a piece of the telescoping dilator from the placement kit used in the procedure. The piece was removed from the patient. Per additional information received (b)(6) 2020, as of this date the patient was ready to be discharged. The tube that had been inserted was a 16fr gastro-jejunal (gj) tube. The fragment found inside the patient was approximately 9fr in diameter. It had somehow become separated from the device and had been extruded into the bowel during the procedure.
 
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Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR
Type of DeviceDH EF PERC PLACEMENT PRODUCTS
Manufacturer (Section D)
AVANOS MEDICAL INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
AVENT SA DE R.L. DE C.V. (AVENT 1)
circuito industial no.40
colonia obrera
nogales, cp
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key9998110
MDR Text Key189050366
Report Number9611594-2020-00071
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2021
Device Model Number98432
Device Catalogue NumberN/A
Device Lot Number30012240
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/24/2020 Patient Sequence Number: 1
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