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

Model Number	100/399/218
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Premature Separation (4045)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8152166
• Report Number: 3012307300-2018-08735
• Device Sequence Number: 1770657
• 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,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 08/08/2019
• 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