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	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 510k status: exempt.(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
The international distributer reported that there was a hair inside the primary package of the mixter endoscopic cholangiography set.This was discovered prior to the use of the product and no patient contact occurred; accordingly, no patient adverse events resulted from the product problem.The product is reportedly unavailable for return.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation a review of the device history record, instructions for use (ifu), quality control data, and photo inspection was conducted during the investigation.The device was not returned, but 5 pictures of the device confirmed it to be out of specification as foreign matter was visible inside the packaging.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record showed one nonconforming event; however, all non-conforming product was scrapped prior to completion of the final lot.There were no other reported complaints for this lot number.Based on the information provided, examination of the photos provided, and the results of our investigation; the root cause has been attributed to 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: 7201832
• Report Number: 1820334-2018-00006
• Device Sequence Number: 16483060
• Product Code: GBZ
• UDI-Device Identifier: 00827002080454
• UDI-Public: (01)00827002080454(17)200809(10)8128229
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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 Model Number: N/A
• Device Catalogue Number: C-OECS-400-MIXTER
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1