MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number	98433
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The device history record for the reported lot number, aa7184r14, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 01-mar-2019 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 or Problem Description
It was reported that a doctor attempted to use the sutures out of a kit to secure the stomach.Three out of four sutures snapped/broke with very little tension.The doctor did not want to attempt to use the remaining one that was left in the kits, so another kit was opened and used successfully.There was no patient injury reported.
Additional Manufacturer Narrative
Three (3) used suture anchors out of the four in a kit were received.The 4th suture from the kit was not received.There was no packaging information received.The sutures were evaluated and failure was confirmed.The sample provided was evaluated confirming the sutures and anchors were detached from the needles.However; the root cause of the reported issue could not be determined.All information reasonably known as of 28-mar-2019 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).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.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8384645
• Report Number: 9611594-2019-00033
• Device Sequence Number: 303478
• Product Code: KGC
• UDI-Device Identifier: 10680651984330
• UDI-Public: 10680651984330
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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 Expiration Date: 06/01/2019
• Device Model Number: 98433
• Device Catalogue Number: 991098433
• Device Lot Number: AA7184R14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 03/29/2019
• Patient Sequence Number: 1