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

Catalog Number NLD-15597-20

Device Problem Failure to Infuse (2340)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical portex® spinal anesthesia needle was placed successfully.However, it was reported to not be working.Placement was checked by different staff and was noted to be placed correctly.To manage patient discomfort, a secondary route was used.There were no reported adverse effects.

Manufacturer Narrative

One bupivacaine ampule, one lidocaine ampule, and one epinephrine ampule were returned from a portex® spinal anesthesia tray.Visual evaluation of the ampules found no visible non-conformities.The drug liquid was found to be clear (colorless) with no particles visible inside the vials.Review of the device history records, incoming records, and sterilization records found no discrepancies or anomalies.Assay testing performed by the supplier prior to release of the anesthetics were within specification for the drug lot numbers.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Based on available information and evidences, no product quality problem could be confirmed.The root cause is unconfirmed as no fault could be found.

Manufacturer Narrative

Additional information: potential event dates: (b)(6) 2017; potential lot numbers: 3373455, 3371993, 3468284, 3455343.

Event Description

Due to the intubation, the reporter noted that the patient had increased risk of newborn respiratory failure.The reporter was unaware of any complication with the newborn.

• Brand Name: PORTEX® SPINAL ANESTHESIA 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 NH 03431
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7128113
• MDR Text Key: 95381792
• Report Number: 3012307300-2017-02606
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688078688
• UDI-Public: 20351688078688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E332605
• 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,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: NLD-15597-20
• Device Lot Number: 3468284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1