MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL KITS; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The anesthetics are a supplied items and the complaint notification was forwarded to the supplier.Batch record review performed by the supplier for bupivacaine (marcaine) lot #'s 582453a and 511603a revealed no discrepancies that may have contributed to a complaint of this nature.Final release potency testing for all drug components was performed and was within specification requirements.In addition the supplier tested retains and returned samples.All samples met specification requirements.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.The complaint could not be confirmed.
Event or Problem Description
It was reported that a bupivacaine medication in portex® spinal kits was ineffective.No patient injury reported.

• Brand Name: PORTEX® SPINAL KITS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7507955
• Report Number: 3012307300-2018-10148
• Device Sequence Number: 2194601
• Product Code: CAZ
• UDI-Device Identifier: 00351688000326
• UDI-Public: 00351688000326
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: No Information
• Device Catalogue Number: 49661-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BUPIVACAINE