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

Catalog Number 405828

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2019

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.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 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.

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 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8711895
• MDR Text Key: 148804014
• Report Number: 1625685-2019-00052
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: 00382904058289
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 405828
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other