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

Catalog Number 49662-25

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.Examination of the returned box found 26 sealed original trays lot # 3260417.Visual evaluation of one bupivacaine ampule from each returned tray found no visible non-conformities.The drug liquid was found to be clear (colorless) with no particulates visible inside the vials.The anesthetic is a supplied item and the complaint notification was forwarded to the supplier.Records analysis was performed by the supplier for bupivacaine-marcaine lot #'s 641403a and confirmed that the pfizer conducts the testing prior to lot release and throughout the lifecycle to ensure that the product continues to meet all the registered specifications.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.

Event Description

It was reported that a marcaine medication in portex® spinal kits was ineffective and general anesthesia was used.No patient injury reported.

• Brand Name: PORTEX® SPINAL KITS
• 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: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7508183
• MDR Text Key: 108152288
• Report Number: 3012307300-2018-10226
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688051311
• UDI-Public: 00351688051311
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 49662-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1