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	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that after removing the tray spn spt24g3.5 b/l/e from the patient after the spinal procedure, the hub dislodged and the sprotte spinal needle remained partially inside the patient, leaking fluid from the back.The needle was removed with no reported adverse effects.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: as the doctor was removing the introducer from the patient after her spinal procedure, the hub came dislodged and the sprotte 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.
Event or Problem Description
It was reported that after removing the tray spn spt24g3.5 b/l/e from the patient after the spinal procedure, the hub dislodged and the sprotte spinal needle remained partially inside the patient, leaking fluid from the back.The needle was removed with no reported adverse effects.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: as the doctor was removing the introducer from the patient after her spinal procedure, the hub came dislodged and the sprotte 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: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

• 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: 8861280
• Report Number: 1625685-2019-00084
• Device Sequence Number: 311000
• 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: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: Health Professional
• Device Catalogue Number: 405707
• Device Lot Number: UNKNOWN
• 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: 08/20/2019
• 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