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

Model Number	100/399/216
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
H10: no product or photographic evidence were provided to aid in this investigation.As a result, a complaint investigation / product evaluation and problem confirmation cannot be performed.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.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.

• Brand Name: PORTEX EPIDURAL CATHETER SECUREMENT DEVICES
• Common Device Name: 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: 15955494
• Report Number: 3012307300-2022-27809
• Device Sequence Number: 20473362
• Product Code: BSO
• UDI-Device Identifier: 10351688068132
• UDI-Public: 00351688068135
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K051524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown