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

Model Number 405699

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

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 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. ".

• Brand Name: BD WHITACRE¿ SPINAL TRAY
• Type of Device: 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
• MDR Text Key: 283612587
• Report Number: 1625685-2021-00101
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• 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: 03/10/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial