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

Catalog Number 100/382/118CZ

Device Problems Break (1069); Material Deformation (2976)

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

Event Type  malfunction  

Event Description

It was reported that the anesthesiology and nursing team's report follows: during catheter removal, it is very flexible, reaching the point of elongation, hence the ease of breaking.No patient injury was reported.

Manufacturer Narrative

Other, other text: d5 is unknown, no information provided to date d4: udi number is unknown h6: event problem and evaluation codes: updated.H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three product samples were received for evaluation.Visual inspection found the catheters were flexed and torn as described by customer.Based on complaint description and complaint samples conditions it is the most probable that customer did not follow instructions for use - do not remove catheter when stretching is observed.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX EPIDURAL CATHETERS
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17213305
• MDR Text Key: 318083844
• Report Number: 3012307300-2023-06752
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K062005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/382/118CZ
• Device Lot Number: 4087830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1