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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 DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98430
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/19/2022
Event Type  malfunction  
Manufacturer Narrative
The actual complaint product was not returned for evaluation. A review of the device history record is in-progress. All information reasonably known as of 11 may 2022 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. 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 the physician performed an introducer placement kit (ipk) to mickey-g procedure; it was endoscopically monitored. After the serial dilator was removed and the tube was placed the physician noted, while removing the guidewire, that a small white plastic piece was stuck on the guidewire at the base of the g-tube; it was the tip of the dilator, which had snapped off inside of the patient. The physician stated that it was small enough to pass through [the patient¿s intestines]. There was no reported injury to the patient. No additional information was provided concerning the passing of the tip of the dilator.
 
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Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE
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 Key14402516
MDR Text Key292358420
Report Number9611594-2022-00061
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,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98430
Device Catalogue NumberN/A
Device Lot Number30136727
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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