MAUDE Adverse Event Report: CAREFUSION, INC EPIDURAL TRAY PERISAFE¿ CONTINUOUS TUOHY 18 GAUGE 3-1/2 INCH; ANESTHESIA CONDUCTION KIT

Catalog Number	406047
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional 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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that epidural tray perisafe continuous tuohy 18 gauge 3-1/2 inch had the wrong catheter inside the tray.This was discovered before use.The following information was provided by the initial reporter: material no: 406047 batch no: unknown.It was reported that the wrong catheter was inside the tray.
Event or Problem Description
It was reported that epidural tray perisafe¿ continuous tuohy 18 gauge 3-1/2 inch had the wrong catheter inside the tray.This was discovered before use.The following information was provided by the initial reporter: material no: 406047, batch no: unknown it was reported that the wrong catheter was inside the tray.
Additional Manufacturer Narrative
Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.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.

• Brand Name: EPIDURAL TRAY PERISAFE¿ CONTINUOUS TUOHY 18 GAUGE 3-1/2 INCH
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9117411
• Report Number: 1625685-2019-00114
• Device Sequence Number: 11302251
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (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): 10/01/2019

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 Catalogue Number: 406047
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other