MAUDE Adverse Event Report: CAREFUSION 2200, INC LUMBAR PUNCTURE TRAY; NEEDLE, SPINAL, SHORT TERM

Model Number 4301C

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2019

Event Type  malfunction  

Event Description

Lumbar puncture trays opened x 2 and both found to have debris on the collection tubes.Manufacturer response for adult lumbar puncture tray, adult lumbar puncture tray (per site reporter).Equipment failure called to bd representative.Arrangements made to return involved equipment to bd.(b)(6).(b)(4).

• Brand Name: LUMBAR PUNCTURE TRAY
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 8416013
• MDR Text Key: 138658663
• Report Number: 8416013
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2019,02/26/2019

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: No Information
• Device Model Number: 4301C
• Device Catalogue Number: 4301C
• Device Lot Number: 001265024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1