MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; NEEDLE, SPINAL, SHORT TERM

Model Number 100/496/126

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 09/24/2020

Event Type  malfunction  

Event Description

It was reported that a smiths medical needle broke inside the patient during a difficult spinal anesthesia.No adverse patient effects were reported.

Manufacturer Narrative

Other, additional information- two needles were returned to smiths medical for evaluation.These samples are being shipped to supplier of component for analysis.The visual inspection performed by smiths medical did not identify.A root cause of the break.

• Brand Name: PORTEX
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10767631
• MDR Text Key: 214090914
• Report Number: 3012307300-2020-10883
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/496/126
• Device Catalogue Number: 100/496/126
• Device Lot Number: 4001029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1