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

Model Number	98430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 22 jul 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 halyard health complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
It was reported that "one of the sutures broke when the dilator was inserted into the stoma after the sutures being placed." no patient injury was reported.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.One used sample was received without product packaging.The sutures were intact and attached to the suture anchor at the proximal end; there was no t-bar fastener at the distal end.The reported failure of broken sutures is confirmed based on absence of the t-bar fastener; however, the root cause could not be determined.The device history record for lot aa8239r12 was reviewed and the product was produced according to product specifications.All information reasonably known as of 11 sep 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 halyard health complaint database and identified as complaint (b)(4).
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The investigation is in progress.All information reasonably known as of 08 aug 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 halyard health 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
• Common Device Name: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8815523
• Report Number: 9611594-2019-00143
• Device Sequence Number: 10848530
• Product Code: KGC
• UDI-Device Identifier: 10680651984309
• UDI-Public: 10680651984309
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2019

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: 07/01/2020
• Device Model Number: 98430
• Device Catalogue Number: 991098430
• Device Lot Number: AA8239R12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/01/2019; 08/26/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/09/2019; 09/11/2019
• Patient Sequence Number: 1