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

Model Number	100/399/216
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Visual inspection revealed that the cover (flap portion) of the locking mechanism on the lock-it plus device was missing, thus confirming the complaint.Magnification of the device showed that the base portion of the locking mechanism was intact and was fully formed.It did not appear to have been damaged.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.Operator of device and if the initial reporter also sent report to fda is unknown.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 or Problem Description
It was reported that during the placement of the epidural, when the anesthetist wanted to close the mobile part of the sample, this sample was broken.No patient injury was reported.

• Brand Name: PORTEX LOCKIT PLUS EPIDURAL CATHETER SECUREMENT DE
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• 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; minneapolis, MN 55442
• MDR Report Key: 15329853
• Report Number: 3012307300-2022-17101
• Device Sequence Number: 12106089
• Product Code: BSO
• UDI-Device Identifier: 00351688068135
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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 Expiration Date: 05/08/2024
• Device Model Number: 100/399/216
• Device Catalogue Number: 100/399/216
• Device Lot Number: 3816710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• 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: 04/11/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female