MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX DURAFLEX PLUS WIRE REINFORCED CATHETERS; ANESTHESIA CONDUCTION KIT

Model Number 4917M-19

Device Problems Break (1069); Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported that the catheter disconnected from the epidural catheter during labor.Few other instances the catheter appeared to have a hole allowing infusion solution to leak.One recent where the catheter broke off.No patient injury was reported.

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be completed.No product sample has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.The reported problem could not be verified and/or confirmed with confidence, therefore no further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX DURAFLEX PLUS WIRE REINFORCED CATHETERS
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: 15316102
• MDR Text Key: 305276045
• Report Number: 3012307300-2022-16603
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688047574
• UDI-Public: 00351688047574
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092657
• 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

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4917M-19
• Device Catalogue Number: 4917M-19
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• 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