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

Catalog Number	40615
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).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 there were 10 occurrences with catheter guide wire being assemble incorrectly with a bd tray epid cont¿ we17g3.5 swc x3796.The following information was provided by the initial reporter: it was reported that the catheter guide wire is being assembled backwards.Per dr.: the new epidural kits i will say the catheter is not being assembled correctly.The guide that helps the catheter go through the needle is on backwards and we have to take it off and then slide it back on, handling the catheter multiple times.Not good for infection control or when you need to get it in quickly.
Additional Manufacturer Narrative
Investigation: one photo was received for evaluation.The customer provided photograph confirmed the reported failure mode, the guide wire was assembled backwards.The most probable root cause of the reported failure mode is improper assembly of the catheter by the applicable manufacturing personnel.A device history record review could not be completed as no batch number was provided.
Event or Problem Description
It was reported that there were 10 occurrences with catheter guide wire being assemble incorrectly with a bd tray epid cont¿ we17g3.5 swc x3796.The following information was provided by the initial reporter: it was reported that the catheter guide wire is being assembled backwards.Per dr.: the new epidural kits i will say the catheter is not being assembled correctly.The guide that helps the catheter go through the needle is on backwards and we have to take it off and then slide it back on, handling the catheter multiple times.Not good for infection control or when you need to get it in quickly.

• Brand Name: BD 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: 8571076
• Report Number: 1625685-2019-00023
• Device Sequence Number: 13862760
• 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: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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 Catalogue Number: 40615
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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