MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX COMBINED SPINAL EPIDURAL TRAYS; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number A4183-17/27

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

It was reported that the epidural clamps disconnect even while still locked.No patient injury was reported.

Manufacturer Narrative

Other, other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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.Premarket (510k) number is unknown.This remediation mdr was generated under protocol (b)(6), as a result of warning letter cms# 617147.

• Brand Name: PORTEX COMBINED SPINAL EPIDURAL TRAYS
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• 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; minneapolis, MN 55442
• MDR Report Key: 15311641
• MDR Text Key: 305380670
• Report Number: 3012307300-2022-16524
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30351688082255
• UDI-Public: 30351688082255
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2022

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: A4183-17/27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/29/2022
• 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