MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN QNKE22G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Catalog Number	405609
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that the tray spn qnke22g3.5 l/b-d/e experienced tip/luer syringe breakage during use.The following information was provided by the initial reporter: material no.405609 batch no.0001275414.Cn called stating that the glass syringe tip of the anaesthesia tray cat no.405609 lot no.Ooo1275414 , broke off at the tip during use.No injury or harm, product did not touch patient, date of incident (b)(6) 2019.
Event or Problem Description
It was reported that thetray spn qnke22g3.5 l/b-d/e experienced tip/luer syringe breakage during use.The following information was provided by the initial reporter: material no.405609, batch no.0001275414.Cn called stating that the glass syringe tip of the anaethasia tray cat no.405609, lot no.Ooo1275414, broke off at the tip during use.No injury or harm, product did not touch patient, date of incident (b)(6) 2019.
Additional Manufacturer Narrative
Investigation: no complaint sample was provided for evaluation.Consequently, the investigation was not able to confirm the reported failure mode.The complaint investigation was unable to confirm the reported failure mode; no contributing factors were able to be identified as no sample was provided for evaluation.The investigation did note the glass syringe is a supplied part and is not altered by the mannford site prior to placement in the finished good tray.Consequently, a probable root cause could not be identified for the mannford manufacturing facility based on the investigation results.A device history record review of all applicable manufacturing records for lot 0001275414 did not identify any issues that may have contributed to the reported failure mode.

• Brand Name: TRAY SPN QNKE22G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8700744
• Report Number: 1625685-2019-00048
• Device Sequence Number: 16605479
• Product Code: CAZ
• UDI-Device Identifier: 00382904056094
• UDI-Public: 00382904056094
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 405609
• Device Lot Number: 0001275414
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/14/2019
• 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