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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. ENTERAL ACCESS DILATION SYSTEM DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. ENTERAL ACCESS DILATION SYSTEM DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98705
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/08/2021
Event Type  malfunction  
Event Description
It was reported a piece of a telescoping dilator broke off inside of a patient. Additional information received 14-oct-2021 stated the physician "noticed when pulling the dilators back out, it was difficult and the innermost one did not catch on the second one as it should have and the second one advanced into the patient. Upon removal of the dilators, the physician could barely see the one that was in the stomach, attempted to remove it via snare (was unsuccessful). The g-tube was placed and the patient went to the gi (gastro intestinal) lab to have this foreign body removed. " the broken piece was removed via endoscopy on (b)(6) 2021. The patient was doing well, no complications.
 
Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation. A review of the device history record is in-progress. All information reasonably known as of 08-nov-2021 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, inc. Complaint database and identified as complaint (b)(4).
 
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Brand NameENTERAL ACCESS DILATION SYSTEM
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 Key12781609
MDR Text Key281336625
Report Number9611594-2021-00158
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98705
Device Catalogue NumberN/A
Device Lot Number30136520
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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