MAUDE Adverse Event Report: CAREFUSION, INC TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795; ANESTHESIA CONDUCTION KIT

Catalog Number 405828

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

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.Device expiration date: unknown.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.No root cause can be determined as no samples were received.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.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: undetermined.

Event Description

It was reported that breakage occurred with a tray cse whit27g4.7 we17g3.5 swc x3795.The following information was provided by the initial reporter, "it was reported that three glass syringes were received broken (5 ml lor syringe); one was cracked down the barrel of the syringe.Discovered upon opening package." 3 occurrences were reported each before use.

• Brand Name: TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795
• 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: 8685065
• MDR Text Key: 147595760
• Report Number: 1625685-2019-00042
• 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: 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
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• 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