MAUDE Adverse Event Report: CAREFUSION, INC 24GX3.5IN WHIT 20G SPINAL INTRO CLEAR; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 400868

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4).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 24gx3.5in whit 20g spinal intro clear needle was found to be blocked after placement.The following information was provided by the initial reporter: "failed spinal despite easy placement with csf (cerebrospinal fluid) swirl.".

Manufacturer Narrative

H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001398064 was performed and no recorded quality problems or rejections related to this incident were found.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h.10.

Event Description

It was reported that the 24gx3.5in whit 20g spinal intro clear needle was found to be blocked after placement.The following information was provided by the initial reporter: "failed spinal despite easy placement with csf (cerebrospinal fluid) swirl.".

• Brand Name: 24GX3.5IN WHIT 20G SPINAL INTRO CLEAR
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12379727
• MDR Text Key: 270090051
• Report Number: 1625685-2021-00056
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 400868
• Device Lot Number: 0001398064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female