MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98430
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was 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 or Problem Description
Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the third of three reports.Refer to 9611594-2020-00093 for the first report, refer to 9611594-2020-00094 for the second report.It was reported by the hospital via the distributor that the sutures failed within 48 hours of placement.Per additional information received 2 jun 2020, the patient is stable, and no follow up was required.
Additional Manufacturer Narrative
All information reasonably known as of 30 jul 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 complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
Event or Problem Description
Per information received on 23 jul 2020 from mhra in ref (b)(4), "radiologically inserted gastrostomy (rig) falling out prematurely.Rig insertion (b)(6) 2020.Number of sutures 3 of 3 day 1 past review - fixator disk at 5cm, 3 sutures present.Slight pain on movement.Within first 2 week review - day 6 all sutures fallen off, from nurses 2 x fell off day 2 post procedure and last one fell off day 6 post procedure.Moved 6-5cm day 1 post rig.Email sent to interventional radiology following sutures falling off." event date is (b)(6) 2020 for two sutures falling and (b)(6) 2020 for all three sutures being gone.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10128614
• Report Number: 9611594-2020-00095
• Device Sequence Number: 2241135
• Product Code: KGC
• UDI-Device Identifier: 00350770984308
• UDI-Public: 00350770984308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 98430
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/31/2020
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 48