MAUDE Adverse Event Report: CAREFUSION, INC BD¿ COMBINED SPINAL & EPIDURAL TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number 405828

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Pma / 510(k) #: enforcement discretion.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history review could not be completed as no batch number was provided.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: no root cause can be determined as no samples were received.Rationale: no batch#/sample available.

Event Description

It was reported that bd¿ combined spinal & epidural trays were used and a needle stick injury occurred with a dirty needle.The following information was provided by the initial reporter: material no: 405828.Batch no: unknown.It was reported that a needle stick occurred.Unknown with which needle in tray this occurred with.Dirty stick.No further information is available from bd rep or customer.

• Brand Name: BD¿ COMBINED SPINAL & EPIDURAL TRAYS
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8701533
• MDR Text Key: 193676478
• Report Number: 1625685-2019-00049
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: 00382904058289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.10
• 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
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405828
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other