• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR DH EF PERC PLACEMENT PRODUCTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98434
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/29/2021
Event Type  malfunction  
Manufacturer Narrative
The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. Root cause could not be determined. All information reasonably known as of (b)(6) 2021 has been included in this health authority report. 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, inc. Complaint database and identified as (b)(4). The device was not returned.
 
Event Description
It was reported there was "an issue with an introducer kit where there was a portion of the serial dilator that was retained during the case. " there was no reported injury. Additional information received (b)(6) 2021 stating the distal piece of the serial dilator sheath was dislodged and was not able to be retrieved at the time of the procedure. Patient underwent an esophago gastroduodenoscopy (egd) to retrieve the pieces. It was noted on a subsequent fiberoptic endoscopic evaluation of swallowing (fees) study on (b)(6) 2021 there was a foreign body in the esophagus so the patient had a second egd to remove another piece of the serial dilator.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR 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 Key12911722
MDR Text Key283331902
Report Number9611594-2021-00165
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 Other,Health Professional,User Facility,Company Representative
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98434
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-