MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX LOCK-IT PLUS ANESTHESIA CATHETER SECUREMENT; CATHETER, CONDUCTION, ANESTHETIC

Model Number 100/399/218

Device Problems Fracture (1260); Device Contamination with Body Fluid (2317)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the customer noticed it was broken.A blood mark was found on it.No patient injury or adverse affects.No additional information is available for this complaint at this time.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual inspection was performed.Visual inspection found the cover (flap), which is part of the clamp, was missing.It also contained a dark mark in one of the corners thus confirming the complaint.Due to the device being removed from the packaging and the adhesive cover being removed, it cannot be determined when the cover became missing or when the dark mark became attached to the device.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.

• Brand Name: PORTEX LOCK-IT PLUS ANESTHESIA CATHETER SECUREMENT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14986294
• MDR Text Key: 303719069
• Report Number: 3012307300-2022-13252
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

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 Operator: Health Professional
• 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: 07/01/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 08/11/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1