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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN ENTERAL FEEDING TUBE DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. UNKNOWN ENTERAL FEEDING TUBE DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number UNKNOWN
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/12/2021
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 12-jan-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, inc. Complaint database and identified as complaint (b)(4).
 
Event Description
It was reported that during a gastrostomy tube placement procedure, the telescoping inner plastic dilator propagated forward and a single portion was retained; the retained portion was retrieved. The device was replaced for a new one; no injury was reported.
 
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Brand NameUNKNOWN ENTERAL 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 Key13251411
MDR Text Key283977061
Report Number9611594-2022-00002
Device Sequence Number1
Product Code KNT
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/23/2022
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received01/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberN/A
Device Lot Number30152469
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/03/2021
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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