MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE; ANESTHESIA CONDUCTION KIT

Catalog Number 405672

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

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

It was reported that the tray spn whit25g3.5 l/b-d/e blue drape experienced foreign matter, contaminated.The following information was provided by the initial reporter: piece of fiber in the syringe.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

(b)(4) follow up mdr for device evaluation: two photos along with the physical sample were provided to our quality team for investigation.Through visual inspection of the physical sample, a plastic fiber was observed inside the syringe, verifying the reported incident.A review of the internal manufacturing device records and raw material history files for reported lot 0001517819 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.This syringe is provided by another bd site who has been notified of this incident.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that the tray spn whit25g3.5 l/b-d/e blue drape experienced foreign matter, contaminated.The following information was provided by the initial reporter: piece of fiber in the syringe.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17914634
• MDR Text Key: 325416553
• Report Number: 1625685-2023-00103
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: (01)00382904056728
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405672
• Device Lot Number: 0001517819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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