MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN SPT24G3.5 B/L/E; ANESTHESIA CONDUCTION KIT

Catalog Number 405707

Device Problem Break (1069)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the tray spn spt24g3.5 b/l/e experienced a needle that broke/pulled out of the hub during use.The following information was provided by the initial reporter: material no.: 405707 batch no.: 0001260927.As physician removed the introducer from the patient after her spinal procedure, the hub came dislodged and the spinal needle partially remained in the patient, dripping fluid from the back.She was able to grasp and remove the needle, and no adverse affects to the patient were reported as a result of the incident.The anesthesia tech has also reported instances of these needles bending.

Manufacturer Narrative

Investigation summary: analysis of the customer provided photograph verified the reported failure mode.The hub was disconnected from the needle.The root cause could not be identified as the defective needle is a supplied part.A quality notification has been issued to the supplier.A review of the device history record revealed no irregularities during the manufacture of the reported lot.

Event Description

It was reported that the tray spn spt24g3.5 b/l/e experienced a needle that broke/pulled out of the hub during use.The following information was provided by the initial reporter: material no.: 405707 batch no.: 0001260927 as physician removed the introducer from the patient after her spinal procedure, the hub came dislodged and the spinal needle partially remained in the patient, dripping fluid from the back.She was able to grasp and remove the needle, and no adverse affects to the patient were reported as a result of the incident.The anesthesia tech has also reported instances of these needles bending.

• Brand Name: TRAY SPN SPT24G3.5 B/L/E
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8859649
• MDR Text Key: 198925197
• Report Number: 1625685-2019-00083
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904057077
• UDI-Public: 00382904057077
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 405707
• Device Lot Number: 0001260927
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other