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

Model Number 100/399/218

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/02/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 306690055
• Report Number: 3012307300-2022-23257
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00351688068142
• UDI-Public: 00351688068142
• 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
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female