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

Model Number 405699

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/01/2021

Event Type  Injury  

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 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.".

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 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
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12104030
• MDR Text Key: 262938775
• Report Number: 1625685-2021-00045
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: 00382904056995
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female