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

Model Number	4910-16/17
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bradycardia (1751); Unspecified Vascular Problem (4441)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2022-26338
• Device Sequence Number: 17734726
• Product Code: CAZ
• UDI-Device Identifier: 00351688032259
• UDI-Public: 00351688032259
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown