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

Catalog Number NEPI-49661-25

Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Pain (1994)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that the bupivacaine was not working again on the patient who was giving birth.The patient experienced a lot of pain during the delivery and had to be put under anesthesia.No further complications were reported in connection with this incident.

• Brand Name: PORTEX SPINAL SINGLE SHOT 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 OH 03431 0724
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7891757
• MDR Text Key: 120821028
• Report Number: 3012307300-2018-03725
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: NEPI-49661-25
• Device Lot Number: 3624023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2018
• 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
• Patient Outcome(s): Required Intervention