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

Model Number 100/399/218

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the customer noticed the lid was unable to be closed, which did not allow him to use it properly.No patient injury reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two used and decontaminate product samples were received for evaluation.Visual and functional testing were performed.No original packaging was present.Visual inspection without magnification, revealed that the cover (flap), was not assembled to the clamp base on one of the returned samples.The cover was found to be adhered to the foam pad of this device.Although the cover was disengaged from the clamp base, the component appeared intact.The cover was reassembled to the base by clicking the hinge (of the cover) into the reciprocating hinge feature of the base.The sample then functioned as intended by closing and opening with an audible click.The second sample required magnification to visually inspect the closure mechanism.This revealed that the hooks, which are located on either side of the cover (flap) of the device, appeared to have been stretched and twisted out of shape.This prevented the locking cover from engaging with the reciprocating lock mechanism (of the base), thus confirming the complaint.The inspection showed that both hooks were fully formed.However, they appeared to have been stretched out of shape by use of force, indicating that the deformity was not the result of a mounding issue (from the supplier).The root cause of the reported issue could not be determined.The information for use (ifu) cautions against applying the securement device in a position where excessive flexing may occur.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.No information has been provided to date this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: LOCKIT PLUS EPIDURAL CATHETER FIXATION 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; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 15299984
• MDR Text Key: 305282219
• Report Number: 3012307300-2022-16332
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00351688068142
• UDI-Public: 00351688068142
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2022

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
• Device Model Number: 100/399/218
• Device Catalogue Number: 100/399/218
• Device Lot Number: 4019578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1