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

Model Number 183A28

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 24 may 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 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.H3 other text : device not returned.

Event Description

The radiologic technologist reported, during an interlaminar epidural of the lower lumbar a needle broke off in the patient; the physician was able to retrieve the remaining portion.The physician stated that upon advancing the needle there was a point, well before reaching the targeted area where the needle began to bend, when the physician pulled the needle back it snapped (near the lower 1/3 from the hub).

Manufacturer Narrative

The device history record for lot 30115703 was reviewed and the product was produced according to product specifications.The actual sample from the reported event was returned for evaluation.The needle was broken at the medial location and there was a very slight bend in the proximal segment.The two segments were placed next to a ruler and it was noted, the break is located at approximately 8.3cml below the base of the hub collar.When examined under magnification, both segments appeared pinched at the point of the break; the break is located almost exactly at the edge of the black marker; there was no visible damage to the tip.The reported event could be confirmed as reported; however, the root cause is undetermined.All information reasonably known as of 13 jun 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 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
• Type of Device: PAIN MANAGEMENT KITS/TRAYS/NEEDLES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 17006065
• MDR Text Key: 316789316
• Report Number: 9611594-2023-00079
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00193493905850
• UDI-Public: 00193493905850
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

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: 183A28
• Device Lot Number: 30115703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• 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
• Patient Weight: 122 KG