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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, 16FR DILATOR DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98430
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided. The sample is reported to be available, but has not yet been received by the manufacturer. All information reasonably known as of 24 nov 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 inc. Complaint database and identified as complaint (b)(4).
 
Event Description
Avanos medical inc. Received a single report that referenced two different incidences, which were associated with the same unit, involving the same patient. This is the second of two reports. Refer to 9611594-2020-00234 for the first report. It was reported that one of the three gastropexy sutures "fell off" on post-operative day four. By post-operative day nine, a second suture "came away. " the third suture remained in situ on post-operative day 14 "with nil concerns. " no patient injury was reported. Additional information received 13-nov-2020 indicated the device was replaced with a mic g-tube.
 
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Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR 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 Key10900447
MDR Text Key222029945
Report Number9611594-2020-00237
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other,use
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/17/2020
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 Invalid Data

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