MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC., PORTEX SPINAL ANESTHESIA TRAYS; CAZ - ANESTHESIA CONDUCTION KIT

Catalog Number 15753-20

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the provided sample revealed one catheter component connected to the yellow epifuse connector; the connector was assembled to the syringe.The catheter/connector assembly was tested for flow with water and no flow was observed through the distal end of the catheter.During testing it was noted that the water was able to be introduced into the catheter, however it could not pass through the spot where a deformation of the catheter was observed.The physical characteristics of the tubing deformation suggest that the catheter was most likely pinched by an external object and slightly stretched.The catheter length was measured and found to be over specification.The deformation was approximately 3 mm long and located 631 mm from the distal (patient) end of the catheter.Unable to determine root cause for deformed catheter tubing.

Event Description

A report was received stating that the catheter frayed.Attempts have been made to obtain further details.No further information has been made available at this time.No adverse effects to patient reported.

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 follow-up report detailing the results of the evaluation.

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• 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: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4863310
• MDR Text Key: 16297041
• Report Number: 2183502-2015-00429
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 15753-20
• 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: 06/18/2015
• Event Location: Hospital
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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