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

Catalog Number NLD-15597-20

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that a portex® spinal anesthesia tray had a hair in the tray upon opening.No patient injury was reported.

Manufacturer Narrative

One opened portex® spinal anesthesia tray was returned for investigation.Visual inspection revealed that a hair-like foreign matter was sealed within the package.It was determined that the foreign matter was most likely inadvertently transferred to the product by the product personnel.Investigation confirmed the reported event and determined the root cause to be manufacturing.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• 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: 6498113
• MDR Text Key: 72946208
• Report Number: 3012307300-2017-00907
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688078688
• UDI-Public: 20351688078688
• 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: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2018
• Device Catalogue Number: NLD-15597-20
• Device Lot Number: 3364838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• 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