MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX COMBINED SPINAL EPIDURAL ANESTHESIA TRAY WITH DURAFLEX PLUS EPIRDURAL CAT; CAZ- ANESTHESIA CONDUCTION KIT

Catalog Number A3852-17/27

Device Problems Fracture (1260); Device, or device fragments remain in patient (1527)

Patient Problems Foreign body, removal of (2365); Surgical procedure, additional (2564)

Event Date 11/29/2013

Event Type  Injury  

Event Description

User facility reported that during placement of the listed device for use on a patient, the outer plastic sheath of the catheter severed at the 7.5cm mark leaving a portion of the catheter inside the patient.The reporter stated that the patient was given a ct scan for visualization of the catheter prior to surgical removal of the catheter by a neurosurgeon.No permanent adverse effects to patient have been reported.

Manufacturer Narrative

Manufacturer completed the entire form.Additional manufacturer narrative: 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 f/u report detailing the results of the evaluation.

• Brand Name: PORTEX COMBINED SPINAL EPIDURAL ANESTHESIA TRAY WITH DURAFLEX PLUS EPIRDURAL CAT
• Type of Device: CAZ- ANESTHESIA CONDUCTION KIT
• 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: 3581583
• MDR Text Key: 4164683
• Report Number: 2183502-2013-00878
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/01/2014
• Device Catalogue Number: A3852-17/27
• Device Lot Number: 2286142
• 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: 01/09/2014
• Distributor Facility Aware Date: 11/29/2013
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention