MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPACK SYSTEM; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 100/391/118CZ

Device Problem Defective Component (2292)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

H3: other; device not returned to manufacturer.No device was returned for investigation.Therefore, we are unable to confirm the reported problem.If we receive the device, we will reopen the investigation for further evaluation.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

Event Description

It was reported that the catheter bevel was not cutting during the procedure, which occurred with two patients on the same day in different rooms.The event occurred during patient use and there was no harm, injury or adverse event.

• Brand Name: PORTEX EPIDURAL MINIPACK SYSTEM
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19185142
• MDR Text Key: 341296088
• Report Number: 3012307300-2024-03040
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 15019315107351
• UDI-Public: (01)15019315107351(17)271201(10)4310213
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K062005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2024

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: 100/391/118CZ
• Device Lot Number: 4310213
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1