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

Catalog Number	C-OECS-400-MIXTER
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported foreign matter, piece of hair, was found in the sealed sterile package of a mixter endoscopic cholangiography set during incoming inspection.The device did not make patient contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Corrected data: device evaluation: the complainant did not return the complaint device to the manufacturer for investigation.However, a set of photos were provided from the customer and show a hair-like filament of foreign matter towards the bottom of the package.The package was not opened and prior to use, which suggests the device was out of specification.Investigation: a document-based investigation reviewed the following: complaint history, device history record, documentation, instructions for use, and quality control specifications.A review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per the ifu: ¿how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ conclusion: based on the information provided, examination of the device photos, and the results of our investigation, the root cause was determined as cause traced to manufacturing (quality control deficiency).Per the [quality engineering] risk assessment, no further action is required.Appropriate measures were initiated to address this failure mode.As a result, there are new gowning procedures in place that should prevent this failure.The appropriate personnel will be notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new event description information to report at this time.

• 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: 8200089
• Report Number: 1820334-2018-03707
• Device Sequence Number: 16682975
• Product Code: GBZ
• UDI-Device Identifier: 00827002080454
• UDI-Public: (01)00827002080454(17)210227(10)8629196
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 02/27/2021
• Device Catalogue Number: C-OECS-400-MIXTER
• Device Lot Number: 8629196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1