MAUDE Adverse Event Report: CAREFUSION, INC BD REGIONAL ANESTHESIA TRAY SPN WHIT27G3.5; ANETHESIA CONDUCTION KIT

Catalog Number	405727
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported with the use of the bd regional anesthesia tray spn (b)(4) there was an issue with foreign matter.It was stated ¿foreign matter is covering the syringe and the packaging of the product.¿ there was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Investigation summary: two photos were received for evaluation.One photo displays a sealed tray with an orange stain on 1 side of the tyvek lid.The investigation was not able to determine the composition or source for this stain.The other photo displays a syringe inside of a procedural kit.Evaluation of this provided photo was able to confirm the presence of debris on the syringe.However, the investigation was not able to identify the type of debris on the syringe or any potential source for the debris based on the evaluation of the photos.A device history record review could not be completed as no batch number was provided.Based on the results, the investigation was not able to identify a probable root cause for either of the failure modes identified through the evaluation of the provided customer photographs.Since no probable root cause was identified for this failure mode, the investigation was not able to identify specific corrective actions for this complaint.As a preventive action, all applicable mannford manufacturing associates will receive awareness training regarding this specific complaint failure mode.Likewise, the vendor of the applicable syringe component will receive a supplier quality notification regarding the observed debris on the syringe in the customer photograph.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.
Event or Problem Description
It was reported with the use of the bd regional anesthesia tray spn whit27g3.5 there was an issue with foreign matter.It was stated ¿foreign matter is covering the syringe and the packaging of the product.¿ there was no report of injury or further medical intervention.

• Brand Name: BD REGIONAL ANESTHESIA TRAY SPN WHIT27G3.5
• Common Device Name: ANETHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7613866
• Report Number: 1625685-2018-00022
• Device Sequence Number: 205179
• Product Code: CAZ
• UDI-Device Identifier: 00382904057275
• UDI-Public: 00382904057275
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: D219092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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: 405727
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/09/2018
• 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