MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® EPIDURAL MINIPACKS; ANESTHESIA CONDUCTION KIT

Catalog Number A4100-17

Device Problem Material Fragmentation (1261)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 09/19/2017

Event Type  Injury  

Event Description

It was reported that the tip of a catheter remained in the patient upon removal of the smiths medical portex® epidural.The patient had complaints of continued pain and "proper technique of tip removal was done." the event was considered resolved.No further adverse patient effects were reported.

• Brand Name: PORTEX® EPIDURAL MINIPACKS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene NH 03431
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6918674
• MDR Text Key: 88369326
• Report Number: 3012307300-2017-02164
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688081602
• UDI-Public: 20351688081602
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E332605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician Assistant
• Device Catalogue Number: A4100-17
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 100