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

Catalog Number	405707
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8859649
• Report Number: 1625685-2019-00083
• Device Sequence Number: 3294898
• Product Code: CAZ
• UDI-Device Identifier: 00382904057077
• UDI-Public: 00382904057077
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 405707
• Device Lot Number: 0001260927
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other