MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CSECURE NEEDLE SETS; NEEDLE, CONDUCTION, ANESTHETIC

Catalog Number 100/491/718

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

It was reported that the yellow clip which secures the epidural catheter was faulty, as it was not grasping the catheter tightly.There was no patient injury.

Manufacturer Narrative

No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No lot number was provided; therefore, device history record review could not be completed.No information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: CSECURE NEEDLE SETS
• Type of Device: NEEDLE, 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; uq health sciences building; minneapolis, MN 55442
• MDR Report Key: 15327507
• MDR Text Key: 305284730
• Report Number: 3012307300-2022-17003
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K993619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/31/2022

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 Catalogue Number: 100/491/718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1