MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPACK, EPIDURAL ANESTHESIA SYSTEM; CAZ - ANESTHESIOLOGY

Catalog Number 100/391/116

Device Problem Material Fragmentation (1261)

Patient Problem Surgical procedure (2357)

Event Date 02/10/2014

Event Type  Injury  

Event Description

A report was received stating that during insertion of the listed device for the administration of epidural anaesthesia, the catheter broke leaving approximately 4 cm of the catheter inside the patient.A ct scan was performed to visualize the catheter prior to surgical removal.No permanent adverse effects to patient reported.

Manufacturer Narrative

Manufacturer completed the entire form.Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: PORTEX EPIDURAL MINIPACK, EPIDURAL ANESTHESIA SYSTEM
• Type of Device: CAZ - ANESTHESIOLOGY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 10 bowman drive; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3705410
• MDR Text Key: 4246701
• Report Number: 2183502-2014-00122
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: 100/391/116
• Device Lot Number: 2386129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2014
• Distributor Facility Aware Date: 02/10/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 02/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention