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

Catalog Number A2104-17

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

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.(b)(4).

Event Description

It was reported that there was a 25g needle hub detachment.While attempting to inject a patient, "the blue hub piece broke away from the needle." it was reported that the needle was inserted into a patient when the hub broke off.The needle had been sticking out far enough that the physician was able to pull it out easily.No additional adverse health outcomes were reported.

Manufacturer Narrative

One used 25 gauge x 1.5 inch hypodermic needle was returned for investigation.The returned sample was in two parts, with the cannula being separated from the hub of the needle.Microscopic inspection of the sample revealed an insufficient amount of glue present on the cannula.The glue found on the cannula did not form a cone which is typical for the component.Additionally, it was found that the glue did not fully encompass the outside diameter of the cannula at the connection between the cannula and the hub.No glue was visible inside the channel of the hub.Investigation determined that the root cause of the hub detachment was due to a supplier issue.

• Brand Name: PORTEX® CONTINUOUS EPIDURAL TRAY
• 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 0724
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6085177
• MDR Text Key: 59351332
• Report Number: 3012307300-2016-00292
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: A2104-17
• Device Lot Number: 3261213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• 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): Other