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

Model Number 100/399/216

Device Problem Disconnection (1171)

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

Event Date 11/12/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that there was an adherence failure on the product.The epidural needs to be reapplied for at least 5 maternity patients who received this lot, failure did not occur with other lot numbers.

Manufacturer Narrative

No product sample has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.The reported problem could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions taken accordingly.A device history record (dhr) review indicated that in-process the product was inspected using c=0 sampling plan for damaged components and no issues were noted relevant to the complaint.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

Event Description

Additional information was received on 22-dec-2022: a second epidural had been given to one in two patients.

• Brand Name: PORTEX EPIDURAL CATHETER SECUREMENT DEVICES
• 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: 15955126
• MDR Text Key: 308022837
• Report Number: 3012307300-2022-27813
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10351688068132
• UDI-Public: 00351688068135
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/399/216
• Device Catalogue Number: 100/399/216
• Device Lot Number: 4293692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 12/29/2022
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1