MAUDE Adverse Event Report: CAREFUSION, INC BD WHITACRE¿ SPINAL TRAY; ANESTHESIA CONDUCTION KIT

Model Number	405699
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
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 a black particle of foreign matter was found in the bd whitacre¿ spinal tray syringe.The following information was provided by the initial reporter: "the customer reported that on (b)(6) 2021, the anesthesiologist is giving spinal anesthesia to a patient, when he prepares the syringe with the anesthetic medicine of bupivacaine, is going to administer it, observes that the syringe has a colored black particle visible with movement, he speculates that it might be from the plunger of the syringe.".
Event or Problem Description
It was reported that a black particle of foreign matter was found in the bd whitacre¿ spinal tray syringe.The following information was provided by the initial reporter: "the customer reported that on (b)(6) 2021, the anesthesiologist is giving spinal anesthesia to a patient, when he prepares the syringe with the anesthetic medicine of bupivacaine, is going to administer it, observes that the syringe has a colored black particle visible with movement, he speculates that it might be from the plunger of the syringe.".
Additional Manufacturer Narrative
H6: investigation summary: 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 0001420447 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.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: BD WHITACRE¿ SPINAL TRAY
• 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: 13004331
• Report Number: 1625685-2021-00101
• Device Sequence Number: 11816395
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: 00382904056995
• Combination Product (Y/N): N
• 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): 03/10/2022

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 Expiration Date: 04/30/2022
• Device Model Number: 405699
• Device Catalogue Number: 405699
• Device Lot Number: 0001420447
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2021
• 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