MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX NRFIT CUSTOM EPIDURAL CONTINUOUS TRAYS; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number NCE6373JP

Device Problem Failure to Disconnect (2541)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

D4 - expiration date is not available.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that "the epidural needle was punctured, and when the inner tube was attempted to be pulled out, it was stuck and could not be pulled out at all.After repeated attempts, a lot of bleeding was observed.The operator gave up trying to pull out the inner tube.When the inner tube was pulled out afterwards, there was a curve that was stronger than usual, and it seemed to be stuck".The event occurred in the user facility.This occurred during infusion."disinfection and sterilization: eog.Infectious disease: no infectious disease.".

• Brand Name: PORTEX NRFIT CUSTOM EPIDURAL CONTINUOUS TRAYS
• 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; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19088894
• MDR Text Key: 340683170
• Report Number: 3012307300-2024-02406
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2024

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: Other
• Device Catalogue Number: NCE6373JP
• Device Lot Number: 231215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2023
• 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