MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CATHETERS; ANESTHESIA CONDUCTION KIT

Catalog Number	4917M-19
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device not received by manufacturer. 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 when the catheter was removed, black color was noted under the dressing.When the catheter was pulled, it was further noted that the cm markings had ¿rubbed off¿ the catheter and were no longer visible on the catheter but on the skin and maybe in the patient along the tract.There was patient involvement, and unknow patient harm/adverse event reported.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.The catheter tubing was inspected and found to be missing some of the increments along the distal end.These markings are used when inserting the catheter into the epidural space during a procedure.For comparison, a sample from stock(warehouse) was examined.The increments were visible.In this instance, while the allegation was confirmed, the exact problem source could not be identified with any confidence.Review of event log found no relevant information.Review of service history found no service within the last 12 months.The probable cause of the reported problem unknown.

• Brand Name: PORTEX EPIDURAL CATHETERS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20081157
• Report Number: 1217052-2024-00086
• Device Sequence Number: 15387576
• Product Code: CAZ
• UDI-Device Identifier: 00351688047574
• UDI-Public: (01)00351688047574(17)260228(10)4459256
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K092657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 4917M-19
• Device Lot Number: 4459256
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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
• Patient Sex: Unknown