MAUDE Adverse Event Report: CAREFUSION, INC BD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH L; 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	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Address information was not able to be obtained, therefore, nj was used as a place holder.Medical device lot #: 405673 was reported, however, this is not a lot # manufactured for the reported catalog #.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 072353a was reported, however, this is not a lot # manufactured for the reported catalog #.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd spinal anesthesia tray 25 gauge 3.5 inch l the medication was ineffective.This occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the consumer several failed spinals.  "we have had several (approx.5) failed spinals using the bupivicaine out of the bd spinal anesthesia trays, "we have another possible failed spinal from a spinal anesthesia tray used today.
Additional Manufacturer Narrative
H6: investigation summary no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.
Event or Problem Description
It was reported while using bd spinal anesthesia tray 25 gauge 3.5 inch l the medication was ineffective.This occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the consumer several failed spinals.  "we have had several (approx.5) failed spinals using the bupivicaine out of the bd spinal anesthesia trays, "we have another possible failed spinal from a spinal anesthesia tray used today.

• Brand Name: BD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH L
• 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: 14242628
• Report Number: 1625685-2022-00048
• Device Sequence Number: 5015487
• Product Code: CAZ
• UDI-Device Identifier: 00382904056735
• UDI-Public: 00382904056735
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/16/2022

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: Health Professional
• Device Model Number: 405673
• Device Catalogue Number: 405673
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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