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

Catalog Number 24-1300-22

Device Problems Break (1069); Material Separation (1562)

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

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

Udi number and device lot numbers are unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported that the customer experienced an incident whereby the catheter has sheared off approximately 10mm from the tip.Customer advised the tip was in place on insertion but not on removal.Patient had an mri scan and no remains found post-delivery.The patient has since been sent home and is reported to being doing well.Customer had sent this item to their investigation facility who have reviewed under a microscope to find it was a clear cut.

Manufacturer Narrative

Other, other text: the investigation of the complaint was limited because no sample or photos were provided.No lot number was provided for performance of a device history record review.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.

Manufacturer Narrative

H10: no lot number was provided; therefore, device history record review could not be performed.A product sample was received for evaluation.Visual inspection found there is missing part of epidural catheter as described by customer.Based on complaint description and complaint sample condition, 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 (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX CONTINUOUS EPIDURAL TRAY
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15341602
• MDR Text Key: 299137753
• Report Number: 3012307300-2022-17374
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 24-1300-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 09/28/2022; 06/16/2023
• Supplement Dates FDA Received: 10/24/2022; 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention