MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX (PENCIL POINT SPINAL NEEDLE); ANESTHESIA CONDUCTION KIT

Model Number NEPI-49663C-25

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/14/2022

Event Type  malfunction  

Event Description

During routine spinal for primary c-section, the spinal needle from the replacement kit broke and a portion remained inside the patient's back.This was noted after the placement of the spinal during the c-section.The surgeon and patient were informed.X-rays were obtained showing the needle.Neurosurgery was consulted.Ct obtained for better resolution of needle.Patient remained asymptomatic.Decision was made to leave fragment in patient.

• Brand Name: PORTEX (PENCIL POINT SPINAL NEEDLE)
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 15690210
• MDR Text Key: 302589637
• Report Number: 15690210
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEPI-49663C-25
• Device Lot Number: 4290806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2022
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7300 DA
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Race: White