MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX NR FIT EPIDURAL CONTINUOUS TRAY; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number NSE0218MJP

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

D4: udi section, expiration date and h4: manufacture date are unavailable based on the reported lot number in the narrative.G5: 510k is unknown, this catalog number is not sold in the united states.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 while in use with a patient, when passing the catheter through the needle, it gets stuck.Multiple cases occurred.Adverse effects are unknown.

Manufacturer Narrative

H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: four (4) unopened devices with original packaging were received.As a result of observing the tuohy needles, there were no noticeable abnormalities in appearance.The lumen of the epidural needle was also observed, but no abnormalities that could lead to an event were identified.The catheter was passed through the epidural needle to confirm its passability, but there was no resistance.The complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken as the complaint was not confirmed.The manufacturer will continue to monitor trends for this event.

• Brand Name: PORTEX NR FIT EPIDURAL CONTINUOUS TRAY
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18237109
• MDR Text Key: 329383598
• Report Number: 1217052-2023-00000
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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: NSE0218MJP
• Device Lot Number: 230707
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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