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

Catalog Number	405727
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd¿ regional anesthesia trays spn whit27g3.5 were "contaminated".There was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
Medical device lot #: 0001180002.Medical device expiration date: 4/30/2020.Device manufacture date: unknown.Medical device lot #: 0001206284.Medical device expiration date: 6/30/2020.Device manufacture date: unknown.Medical device lot #: 0001231457.Medical device expiration date: 9/30/2020.Device manufacture date: unknown.Medical device lot #: 0001221728.Medical device expiration date: 8/31/2020.Device manufacture date: unknown.Four samples were returned for evaluation.A visual evaluation of the samples confirmed the following: the sample from lot 0001180002 had debris on the 3ml syringe (debris identity could not be confirm by the investigation but appears to be residual debris from the shipping container), the sample from lot 0001206284 had damage to the pvp iodine component causing it to leak within the tray.The sample from lot 0001231457 contained a hair within the tray.Evaluation of the sample from lot 0001221728 was unable to confirm the reported failure mode for this sample.For the identified hair, the most probable cause for the hair was identified as an inadvertent transfer of hair from the applicable manufacturing associate to the affected tray.For the identified debris on the syringe, the most probable cause for the debris was transfer of debris from the shipping container to the affected component prior to placement within the finished good tray.The most probable source for the damaged prep component is damage during transit prior to receipt at the customer.Based on the identified probable root causes, all affected manufacturing associated will receive employee awareness training regarding the identified failure mode and probable root causes.A review of the applicable device history records demonstrated all inspection results passed per the dhr process and no anomalies were noticed during production.
Event or Problem Description
It was reported that the bd regional anesthesia trays spn whit27g3.5 were "contaminated".There was no report of exposure, injury, or medical intervention.

• Brand Name: BD¿ REGIONAL ANESTHESIA TRAY SPN WHIT27G3.5
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7970874
• Report Number: 1625685-2018-00044
• Device Sequence Number: 1774354
• 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: N/A
• 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): 11/28/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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