MAUDE Adverse Event Report: CAREFUSION/ BD ADULT LUMBAR PUNCTURE TRAY

Catalog Number 4301C

Device Problems Leak/Splash (1354); Defective Device (2588)

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

Event Date 02/08/2017

Event Type  Injury  

Event Description

The catheter provided with a lumbar puncture kit leaks and the whole batch is bad, multiple kits leak.Multiple lot numbers are defective.Is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: yes.Event reappeared after reintroduction: yes.

• Brand Name: ADULT LUMBAR PUNCTURE TRAY
• Type of Device: LUMBAR PUNCTURE TRAY
• Manufacturer (Section D): CAREFUSION/ BD; new haven CT 06510
• MDR Report Key: 6325466
• MDR Text Key: 67340757
• Report Number: MW5067829
• Device Sequence Number: 1
• Product Code: FCH
• 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: 02/09/2017

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: 04/30/2019
• Device Catalogue Number: 4301C
• Device Lot Number: 0001003160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 100 YR
• Patient Weight: 52