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

Catalog Number	24-1301-22
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other: device has not been returned to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the connector on the device completely snapped off.There was patient involvement and no adverse event/human harm.
Additional Manufacturer Narrative
D9.Date returned to mfg: 09-may-2024.H6.Investigation codes: updated.Investigation summary: one used decontaminated sample of 007/374/418, which is part of the 24-1301-22 nrfit connector, and one sample of lockit plus - which isn´t part of claimed 24-1301-22 - were received without their original packaging for evaluation.Received samples were visually inspected and there was no problem found.According to the event description the claimed issue was observed at the connector, which wasn´t part of the received samples.Thus, we were unable to further investigate the issue and the root cause remains unknown.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.

• Brand Name: PORTEX EPIDURAL CATHETER
• Common Device Name: 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: 19182297
• Report Number: 3012307300-2024-03016
• Device Sequence Number: 17962032
• Product Code: BSO
• UDI-Device Identifier: 15019517073935
• UDI-Public: (01)15019517073935(17)260603(10)4138095
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K062005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2026
• Device Catalogue Number: 24-1301-22
• Device Lot Number: 4138095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown