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

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported finding a hair inside the device primary package.The observation was made during incoming product inspection.There was no patient contact, accordingly there are no adverse patient consequences.The device is being returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Investigation summary: a review of the documentation, device history record, specifications, drawings, and quality control data were conducted during the investigation.The device was not returned for investigation,but pictures of the device were reviewed and confirmed it to be out of specification as foreign matter was visible inside the packaging.A document based investigation was performed.A review of the device history record found no nonconformances associated with the complaint failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, the root cause was determined to be manufacturing.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET
• Common Device Name: GBZ CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6731538
• Report Number: 1820334-2017-01905
• Device Sequence Number: 1243892
• Product Code: GBZ
• UDI-Device Identifier: 00827002080454
• UDI-Public: (01)00827002080454(17)200322(10)7770100
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: C-OECS-400-MIXTER
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1