MAUDE Adverse Event Report: CAREFUSION, INC TRAY EPID SST18G3.5 S/L; ANESTHESIA CONDUCTION KIT

Model Number	406069
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the tray epid sst18g3.5 s/l came with a metal-tipped glass syringe instead of the correct glass-tipped syringe.The following information was provided by the initial reporter: "it is supposed to have a glass syringe with a glass tip as noted on the package.The tray is coming with a glass syringe with a metal tip and per the physician ¿ cannot be used for these procedures.(huge safety issue)".
Additional Manufacturer Narrative
H6: investigation summary two photo samples were provided to our quality team for investigation.Upon visual inspection of the photos, confirmed that the syringe in the photo is not the 5 ml bd epilor syringe lor glass ls, glass tip.The 5 ml bd epilor syringe lor glass ls, glass tip is the appropriate 5 ml syringe that should be included in every 406069 tray, therefore, the reported failure mode was not confirmed.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 that the tray epid sst18g3.5 s/l came with a metal-tipped glass syringe instead of the correct glass-tipped syringe.The following information was provided by the initial reporter: "it is supposed to have a glass syringe with a glass tip as noted on the package.The tray is coming with a glass syringe with a metal tip and per the physician ¿ cannot be used for these procedures.(huge safety issue)".

• Brand Name: TRAY EPID SST18G3.5 S/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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11458176
• Report Number: 1625685-2021-00022
• Device Sequence Number: 19820094
• Product Code: CAZ
• UDI-Device Identifier: 00382904060695
• UDI-Public: 00382904060695
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/10/2021

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: 406069
• Device Catalogue Number: 406069
• 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: 02/11/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 11/24/2021
• 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