MAUDE Adverse Event Report: COOK INC CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET; GBZ CATHETER, CHOLANGIOGRAPHY

Catalog Number	C-HECS-300
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that when the concord endoscopic cholangiography set was removed from the package and during priming of the catheter, the fluid started spraying out of the side before it got to the distal end of the catheter.Another device was used to complete the procedure.No adverse consequences to the patient or user was reported.

• Brand Name: CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET
• Common Device Name: GBZ CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8167902
• Report Number: 1820334-2018-03824
• Device Sequence Number: 2640468
• Product Code: GBZ
• UDI-Device Identifier: 00827002028470
• UDI-Public: (01)00827002028470(17)180413(10)5800528
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2018
• Device Catalogue Number: C-HECS-300
• Device Lot Number: 5800528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1