MAUDE Adverse Event Report: CAREFUSION, INC BD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH; ANESTHESIA CONDUCTION KIT

Model Number	405673
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd spinal anesthesia tray 25 gauge 3.5 inch the anesthesia was ineffective.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the consumer 5 failed spinals from bd spinal tray.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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 while using bd spinal anesthesia tray 25 gauge 3.5 inch the anesthesia was ineffective.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the consumer 5 failed spinals from bd spinal tray.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11-apr-2022.H.6.Investigation: physical samples were received by our quality team for investigation.Upon visual inspection, it was observed that the ampule surfaces were smooth and not scratched.The ampule was gently swirled, inverted and the contents were viewed.The interior liquid was clear, colorless, and free from visible particulates.No issues were noted; therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001443589 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.

• Brand Name: BD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH
• Common Device Name: ANESTHESIA CONDUCTION KIT
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14110215
• Report Number: 1625685-2022-00046
• Device Sequence Number: 19370139
• Product Code: CAZ
• UDI-Device Identifier: 00382904056735
• UDI-Public: 00382904056735
• 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
• Serviced by Third Party (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): 04/21/2022

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
• Operator of Device: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 405673
• Device Catalogue Number: 405673
• Device Lot Number: 0001443589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown