MAUDE Adverse Event Report: AVANOS MEDICAL INC. TUOHY EPIDURAL NEEDLE 25EA/BOX; PAIN MANAGEMENT KITS/TRAYS/NEEDLES

Model Number	183A12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided.A review of the device history record is in-progress.All information reasonably known as of 17-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.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 the epidural needle broke off in the patient during the procedure.The broken needle segment was removed via a medical procedure.There was no reported injury.Additional information received 30-jun-2020 stated the break was in the middle of the needle.The physician made a small 1cm incision and the broken needle was removed, under fluoroscopy guidance, with a special instrument and the site was sutured.The patient experienced no permanent damage.The patient will follow-up with a physician and the spine surgeon for evaluation of the incision site.
Additional Manufacturer Narrative
The device history record for the reported lot number, 20022602, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided and confirmed the reported incident.A root cause was not identified.All information reasonably known as of 13-aug-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).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: TUOHY EPIDURAL NEEDLE 25EA/BOX
• Common Device Name: PAIN MANAGEMENT KITS/TRAYS/NEEDLES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10290168
• Report Number: 9611594-2020-00127
• Device Sequence Number: 19770321
• Product Code: BSP
• UDI-Device Identifier: 00193493905720
• UDI-Public: 00193493905720
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K000495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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 Expiration Date: 01/01/2025
• Device Model Number: 183A12
• Device Catalogue Number: N/A
• Device Lot Number: 20022602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/14/2020
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 100