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

Catalog Number	49661-25
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual evaluation of a marcaine ampule from each returned tray (11 total) found no visible non-conformities.The drug liquid was found to be clear (colorless) with no particulates visible inside the vial.One drug vial was empty and the liquid inside of it could not be evaluated.Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.Assay testing, performed by the supplier prior to release of bupivacaine-marcaine lot # 662603a, was within specification.Review of the sterilization certificate for the tray lot number 3368839 ((b)(4)) revealed that the product was processed according to validated specification requirements and parameters.Smith medical periodically monitors supplied drug components stability post ethylene oxide sterilization throughout their expiry.Our records show that the supplied drugs components continue to meet potency specifications.Complaint history review does not indicate any upward trends for the drug lot numbers, reported in this complaint.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.
Event or Problem Description
It was reported that the bupivacaine inside the portex® spinal anesthesia tray was ineffective.The anesthesiologist administered the block twice unsuccessfully.The block was only successful on the third attempt.Even then block took 20 minutes to take effect and was ".Was not that deep."there were no allegations of malfunction with respect to the other components of the kit.No serious injury was reported in connection with this incident.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7507697
• Report Number: 3012307300-2018-10275
• Device Sequence Number: 167571
• Product Code: CAZ
• UDI-Device Identifier: 00351688000326
• UDI-Public: 00351688000326
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: E332605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: 49661-25
• Device Lot Number: 3368839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1