MAUDE Adverse Event Report: CAREFUSION, INC TRAY EPID CONT WE17G3.5 SWC X3796; ANESTHESIA CONDUCTION KIT

Catalog Number	406151
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/01/2019
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 separation occurred with a tray epid cont we17g3.5 swc x3796.The following information was provided by the initial reporter, "of course, my patient was complete and laboring down we were using the peanut ball and moving side to side.After doing that she called out saying she was starting to feel some pressure we started pushing during that time is when it must broke, because half way through she was in extreme pain.We called (b)(6) the crna and he came to evaluate the patient and saw it disconnected and not working at this time he replaced the cle and the patient was able to deliver and push and deliver.".
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that separation occurred with a tray epid cont we17g3.5 swc x3796.The following information was provided by the initial reporter, "of course, my patient was complete and laboring down we were using the peanut ball and moving side to side.After doing that she called out saying she was starting to feel some pressure we started pushing during that time is when it must broke, because half way through she was in extreme pain.We called roy the crna and he came to evaluate the patient and saw it disconnected and not working at this time he replaced the cle and the patient was able to deliver and push and deliver.".

• Brand Name: TRAY EPID CONT WE17G3.5 SWC X3796
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9106484
• Report Number: 1625685-2019-00112
• Device Sequence Number: 19364536
• Product Code: CAZ
• UDI-Device Identifier: 00382904061517
• UDI-Public: 00382904061517
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/23/2019

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: 09/30/2020
• Device Catalogue Number: 406151
• Device Lot Number: 0001305208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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