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

Model Number	100/399/218
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product sample has been provided to the site.Without a returned product, the investigation could not be confirmed whether a quality related issue has been found.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 take further actions accordingly.Device history record review found no discrepancies or anomalies relevant to complaint.
Event or Problem Description
The plastic catheter securement device dislodged from the soft dressing.The rupture of the device led to an accidental removal of the catheter.A second epidural catheter had to be inserted.No further incident observed afterward.Additional information received on 29-sep-2022: device was changed.No further issue observed.

• Brand Name: LOCKIT PLUS EPIDURAL CATHETER SECUREMENT DEVICE
• 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: 15580840
• Report Number: 3012307300-2022-23257
• Device Sequence Number: 6345471
• Product Code: BSO
• UDI-Device Identifier: 00351688068142
• UDI-Public: 00351688068142
• 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
• Report Date (Section B): 10/11/2022

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 Model Number: 100/399/218
• Device Catalogue Number: 100/399/218
• Device Lot Number: 4239879
• 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: 09/13/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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
• Patient Sex: Female