MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TUOHY EPIDURAL NEEDLE, 18G, 110MM; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number 100/395/580

Device Problems Material Separation (1562); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: one used device was returned for investigation.Visual inspection noticed that the needle was broken in two pieces and one of them was also bent.The complaint was confirmed.It is highly improbable that such defective needle passed the quality inspection system.There haven't been received similar customer complaints, therefore this issue is considered to be isolated incident only with unknown root cause.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

Event Description

It was reported: ¿i am a medically responsible anesthetist in vasteras and yesterday i was informed about an incident where one of my colleagues tried to put an eda on an obese woman in labour.After a while, my colleague thought that the eda needle felt strange inside the patient and then chose to back out.The needle was then found bent in two places.When she laid it down on the table the distal part came off.The incident was reported in our deviation management system (synergi case number 229677)." there was patient involvement.There was no adverse event/human harm.

• Brand Name: PORTEX TUOHY EPIDURAL NEEDLE, 18G, 110MM
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapoplis, MN 55442 ; 2247062300
• MDR Report Key: 19176978
• MDR Text Key: 341294178
• Report Number: 3012307300-2024-03003
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K090261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2024

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 Catalogue Number: 100/395/580
• Device Lot Number: 4178317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• 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