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

Model Number 100/399/218

Device Problems Detachment of Device or Device Component (2907); Premature Separation (4045)

Patient Problem Awareness during Anaesthesia (1707)

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Information was received that a smiths medical portex lockit plus regional anesthesia catheter securement device became detached while in use with a patient.The reporter stated the detachment resulted in the catheter pulling out of the epidural space, which caused the epidural pain control to be insufficient.Subsequently, the nurses had to insert a new epidural catheter and a more invasive method of anesthesia intervention was required, noted as either, "general anesthesia or emergency cesarean section".No additional adverse patient effects were reported.

Manufacturer Narrative

Two unused catheter securement devices were returned for evaluation.Visual inspection of the devices found them to be adhered to the fixture and the catheter was threaded through lockit.Functional testing of the devices included setting the tensile tester to pull at 12 in per minute and stop at 6 in; noting that if catheter breaks or pulls, it is considered a failure.The samples remained in lockit for duration of the test, indicating an acceptable performance.The reported customer complaint was unable to be confirmed.This investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• Brand Name: PORTEX LOCKIT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8152166
• MDR Text Key: 129952548
• Report Number: 3012307300-2018-08735
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00351688068142
• UDI-Public: 00351688068142
• Combination Product (y/n): N
• PMA/PMN Number: K051524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2022
• Device Model Number: 100/399/218
• Device Catalogue Number: 100/399/218
• Device Lot Number: 3541317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention