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

Catalog Number 406151

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event 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.".

Manufacturer Narrative

Further information was requested but not received.

Event 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9106484
• MDR Text Key: 195228856
• Report Number: 1625685-2019-00112
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904061517
• UDI-Public: 00382904061517
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other