MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN TUOHY NEEDLE; REGIONAL ANESTHESIA

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported "during the procedure a 20- gauge 3.5 tuohy needle.Was advanced towards the epidural space at l4-5 under direct fluoroscopic guidance using loss-of-resistance to saline.[the physician] never obtained a loss of resistance to saline; however, [the physician] also never felt any significant resistance to needle advancement.After reaching the limit of the 3-1/2-inch touhy needle without obtaining epidural access, [the physician] obtained another lateral image and noted that the epidural needle was actually bent at approximately a 30-degree angle.[the physician] then planned to remove the needle and repeat the approach using an 18-guage 6-inch touhy.Upon removing the needle, it was noted that the needle had actually fractured at approximately 1.5 inches from the hub of the needle.As a result of the distal end of the needle fracturing, it was necessary to take [patient] to the operating room, where [the patient] was placed under general anesthesia, and the retained needle tip was identified and removed by blunt dissection under fluoroscopic imaging.".

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 29-dec-2023 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: UNKNOWN TUOHY NEEDLE
• Type of Device: REGIONAL ANESTHESIA
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18421006
• MDR Text Key: 331714326
• Report Number: 2026095-2023-00116
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2023

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female