MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 25G1.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Model Number	405675
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
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 tray spn whit25g3.5 25g1.5 l/b-d/e was labeled incorrectly, with fill markings incorrectly placed.The following information was provided by the initial reporter: "hash marks on 5ml syringe in epidural kit do not line up with the hub/base of the syringe.This could have resulted in delivering approx 1ml additional medication than intended.Anesthesiologist, dr , noted issue upon drawing up medication and handed off mis-marked syringe immediately.New kit opened--same manuf number, same lot number but the syringe within was correct.".
Event or Problem Description
It was reported tray spn whit25g3.5 25g1.5 l/b-d/e was labeled incorrectly, with fill markings incorrectly placed.The following information was provided by the initial reporter: "hash marks on 5ml syringe in epidural kit do not line up with the hub/base of the syringe.This could have resulted in delivering approx 1ml additional medication than intended.Anesthesiologist, dr , noted issue upon drawing up medication and handed off mis-marked syringe immediately.New kit opened--same manuf number, same lot number but the syringe within was correct.".
Additional Manufacturer Narrative
Correction: the following fields were corrected: d4: medical device lot #: unknown.The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-01-27.H6: investigation summary: one physical sample was returned to our quality team for investigation.Through visual inspection, it was observed that the syringe markings did not line up properly with the base of the syringe therefore, the reported failure mode was confirmed.A device history review could not be completed as no batch number was provided.Based on the available information, the root cause of the issue correspond to a supplier defect, scar was issued to the supplier complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: TRAY SPN WHIT25G3.5 25G1.5 L/B-D/E
• 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: 12256194
• Report Number: 1625685-2021-00048
• Device Sequence Number: 3682567
• Product Code: CAZ
• UDI-Device Identifier: 00382904056759
• UDI-Public: 00382904056759
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/27/2022

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: 405675
• Device Catalogue Number: 405675
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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