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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. PORTEX® SPINAL KITS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NLD-15597-20
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Visual evaluation of s50 bupivacaine ampules from the returned trays found no visible non-conformities. The drug liquid was found to be clear (colorless) with no particulates visible inside the vials. 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 # 66-249-ev, was within specification. Review of the sterilization certificate for the tray lot number 3339107 (po # (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 Description
It was reported that a bupivacaine medication in portex® spinal kits was failing on patient. No patient injury reported.
 
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Brand NamePORTEX® SPINAL KITS
Type of DeviceANESTHESIA 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 Key7508229
MDR Text Key108156709
Report Number3012307300-2018-10258
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNLD-15597-20
Device Lot Number3339107
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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