MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX KITS OTHER; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER

Catalog Number NSC1827PCJP

Device Problems Break (1069); Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.As a result of observing the sample, it was confirmed that the catheter was cut in two.The total length of the catheter was measured, but no elongation could be confirmed the root cause of the reported issue was found to be highly probable that the catheter was damaged due to contact with scissors during use.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that after indwelling the catheter in the epidural space, the customer noticed the catheter was torn.No patient injury was reported.

• Brand Name: PORTEX KITS OTHER
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-21-2, motohama-cho, naka-ku,; minneapolis, MN 55442
• MDR Report Key: 15397999
• MDR Text Key: 305257341
• Report Number: 3012307300-2022-18598
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171968
• 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
• Report Date: 09/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSC1827PCJP
• Device Lot Number: 4044647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Race: Asian