MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX DURAFLEX ANESTHESIA CATHETER; ANESTHESIA CONDUCTION KIT

Model Number 4910-16/17

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bradycardia (1751); Unspecified Vascular Problem (4441)

Event Date 09/27/2022

Event Type  Injury  

Event Description

It was reported that an epidural catheter was in use on a patient in labor.The catheter went intravascular on two separate attempts.Fetal heart rate dropped and patient needed expedited vacuum delivery.Reportedly, "[the] baby and mom were fine." product lot number is unknown.

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.No lot number was provided for performance of a device history record review.

• Brand Name: PORTEX DURAFLEX ANESTHESIA CATHETER
• 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; 14th floor, north tower; minneapolis, MN 55442
• MDR Report Key: 15679850
• MDR Text Key: 302484329
• Report Number: 3012307300-2022-26338
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688032259
• UDI-Public: 00351688032259
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4910-16/17
• Device Catalogue Number: 4910-16/17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/27/2022
• 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
• Patient Outcome(s): Required Intervention