MAUDE Adverse Event Report: NULL PORTEX SPINAL NEEDLE SETS; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number NEPI-NLD-15597-20

Device Problems Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

Patient Problems Chills (2191); No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

It was reported that a patient experienced drug efficacy during the use of a smiths medical pain management device.

• Brand Name: PORTEX SPINAL NEEDLE SETS
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section G): NULL
• MDR Report Key: 10834475
• MDR Text Key: 216084388
• Report Number: 3012307300-2020-11415
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: NEPI-NLD-15597-20
• Device Catalogue Number: NEPI-NLD-15597-20
• Device Lot Number: 4037241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1