MAUDE Adverse Event Report: AVANOS MEDICAL INC. INJECTION NEEDLE CATHETER; DH ENDOSCOPY INJECTION NEEDLE CATHETERS

Model Number	60817
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): the report states there was an injury as a result of this reported malfunction; however, no details regarding the injury have been provided.The product involved in the report has been returned and is being processed for evaluation.The device history record for lot m18011e112 was reviewed and the product was produced according to product specifications.All information reasonably known as of 03 jun 2019 has been included in this health authority report.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).
Event or Problem Description
It was reported that "egd [esophagogastroduodenoscopy] in epi [epinephrine] needle will not deploy.".
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.One used sample was returned with the original pouch packaging.A second packaging was received; however, no device came with this packaging.The returned sample was reviewed and examined.The reported failure was not confirmed by sample evaluation.A process evaluation was performed and no issues or abnormalities during manufacture of reported lot were found that might have caused the reported failure in the product.The root cause could not be determined.All information reasonably known as of 16 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).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: INJECTION NEEDLE CATHETER
• Common Device Name: DH ENDOSCOPY INJECTION NEEDLE CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8670947
• Report Number: 8030647-2019-00052
• Device Sequence Number: 254484
• Product Code: KDH
• UDI-Device Identifier: 30680651927744
• UDI-Public: 30680651927744
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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: 01/28/2022
• Device Model Number: 60817
• Device Catalogue Number: 991092774
• Device Lot Number: M18011E112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1