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 Underdose (2542)

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical portex® spinal anesthesia tray that was used for spinal anesthesia during a c-section, failed to work.The spinal was reported to be placed correctly with visible csf return.Subsequently, the patient required airway intubation to manage to the delivery of the baby.As a result, it was reported that during intubation, the baby received some anesthesia and was required to be transferred to higher care.No adverse effects were reported.

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.

Manufacturer Narrative

Smiths medical did not receive samples for analysis.However, the device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Assay testing was performed by the supplier prior to release of bupivacaine, lidocaine, and epinephrine with all being within specification.Review of the sterilization certificates revealed that the product was processed according to validated specification requirements and parameters.Records revealed that the supplied drugs components continue to meet potency specifications since they are periodically monitored.Complaint history review showed that it does not indicate any upward trends for the drug lot numbers, reported in this complaint.Based on evidence, no product quality problem could be confirmed.Possible root causes of lack of effect may also be administration technique or patient anatomical variations, including pathological or psychological factors.No corrective action will be conducted at this time will continued to be reviewed.

• 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: 7160230
• MDR Text Key: 96317966
• Report Number: 3012307300-2017-02746
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: NLD-15597-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention