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

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

A report was received stating that the device was in use with a pt overnight when the catheter was observed stretched and severed.The catheter reportedly severed overnight and a portion of the catheter remained in the pt.It is unclear if med intervention was used to remove the foreign body.Additional info has been requested.None is available at this time.No permanent adverse effects to the pt reported.

Manufacturer Narrative

The device has not been returned to them for for device evaluation.When and if the device becomes available and is returned and evaluated, the mfr will file a follow-up report detailing the device evaluation results.

• Brand Name: PORTEX EPIDURAL MINIPACK, EPIDURAL ANESTHESIA SYS
• Type of Device: ANESTHESIOLOGY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4232688
• MDR Text Key: 5072263
• Report Number: 2183502-2014-00669
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2014
• Event Location: Hospital
• Date Manufacturer Received: 08/20/2014
• 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: Unknown
• Patient Sequence Number: 1