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

Catalog Number NEPI-49662-25

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

Portex spinal kit ref: nepi-49662-25, lot: 4159720 spinal kit contained a long blonde hair among sterile instruments.Kit was discarded and a fresh kit that was free of defect was utilized instead.

• Brand Name: PORTEX SPINAL KIT CONTAINE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12960595
• MDR Text Key: 282037188
• Report Number: MW5105900
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: NEPI-49662-25
• Device Lot Number: 4159720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 649 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White