MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT27G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Model Number	405699
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
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 spn whit27g3.5 l/b-d/e needle broke off from the hub while preparing for a c -section, which had to be retrieved by an additional procedure in tertiary care.The following information was provided by the initial reporter: "per customer response: what was the procedure that was being performed? spinal in prep for a c-section.What was the additional procedure that was done to retrieve the needle? this, i do not have the information.What was the patient outcome? required transfer to tertiary care center and additional procedure." "the needle in this tray broke during the procedure and it was not able to be retrieved without an additional procedure.".
Additional Manufacturer Narrative
H6: investigation summary: one sample was provided to our quality team for investigation.Through visual inspection, it was observed that the needle is broken; therefore the reported failure could be verified.As the lot involved in this incident is unknown, a device history review cannot be performed.Based on the quality team's investigation, root cause is user error (the needle broke during the use process) related at this time.
Event or Problem Description
It was reported that the tray spn whit27g3.5 l/b-d/e needle broke off from the hub while preparing for a c section, which had to be retrieved by an additional procedure in tertiary care.The following information was provided by the initial reporter: "per customer response: what was the procedure that was being performed? spinal in prep for a c section.What was the additional procedure that was done to retrieve the needle? this, i do not have the information.What was the patient outcome? required transfer to tertiary care center and additional procedure." "the needle in this tray broke during the procedure and it was not able to be retrieved without an additional procedure.".

• Brand Name: TRAY SPN WHIT27G3.5 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: 12104030
• Report Number: 1625685-2021-00045
• Device Sequence Number: 19876085
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: 00382904056995
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 405699
• Device Catalogue Number: 405699
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 01/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female