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

Catalog Number	405828
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2019
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.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.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: 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.
Event or Problem Description
It was reported that the tray cse whit27g4.7 we17g3.5 swc x3795 blunt fill needle was found on top of the wrapping before use, presenting a sterility issue.The following information was provided by the initial reporter: "inconsistent blunt fill needle on top of wrapping''.Stated that the needle was on top of the wrapping but should be under / wrapped in the wrapping.The sales rep noted that this does cause a sterility issue when opening the tray.
Additional Manufacturer Narrative
Bd was initially made aware of this complaint on 2019-04-30.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 2019-06-04 that changed the reportability determination, thus why the date was used at the date received by manufacturer in the initial mdr.However, further review dictates that the initial awareness date should have been provided in the mdr, and so the following fields have been corrected: date of event: unknown.The date received by manufacturer has been used for this field.Date of event: (b)(6) 2019 date received by manufacturer: 2019-04-30.
Event or Problem Description
It was reported that the tray cse whit27g4.7 we17g3.5 swc x3795 blunt fill needle was found on top of the wrapping before use, presenting a sterility issue.The following information was provided by the initial reporter: "inconsistent blunt fill needle on top of wrapping." stated that the needle was on top of the wrapping but should be under / wrapped in the wrapping.The sales rep noted that this does cause a sterility issue when opening the tray.

• Brand Name: TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8711895
• Report Number: 1625685-2019-00052
• Device Sequence Number: 19297846
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: 00382904058289
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• 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): 07/01/2019

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: 405828
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/01/2019
• 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