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

Catalog Number 406151

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd¿ tray epid cont we17g3.5 swc x3796 catheter was disconnected.This occurred on 5 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no.406151, batch no.Unknown.It was reported that stingray disconnecting from epidural catheter.Per pir: (b)(6) reports that they have had 5 epidural catheter connectors disconnect from the stingray connector, in the last 2 weeks.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

Event Description

It was reported that bd¿ tray epid cont we17g3.5 swc x3796 catheter was disconnected.This occurred on 5 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no.406151 batch no.Unknown it was reported that stingray disconnecting from epidural catheter.Per pir: littleton reports that they have had 5 epidural catheter connectors disconnect from the stingray connector, in the last 2 weeks.

• Brand Name: BD¿ 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: 8750753
• MDR Text Key: 150860676
• Report Number: 1625685-2019-00062
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904061517
• UDI-Public: 00382904061517
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 406151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other