MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EPIFUSE CATHETER CONNECTOR, MODEL: 4909E; ANESTHESIA CONDUCTION KIT

Model Number 4917M-19

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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, catheter had a hole allowing infusion solution to leak, and catheter broke off.No patient injury was reported.

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.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
• 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: 15315664
• MDR Text Key: 305355279
• Report Number: 3012307300-2022-16592
• 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: User Facility
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1