MAUDE Adverse Event Report: COOK INC COOK AIRWAY EXCHANGE CATHETER; LRC CHANGER, TUBE, ENDOTRACHEAL

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
Distributor reported that there was a piece of an unidentified particle inside the primary package of a cook airway exchange catheter.The event was noted during incoming product inspection.There was no patient contact, accordingly there are no adverse patient consequences.The device is available for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control and inspection of photographs of the actual device was conducted during the investigation.Photographs of the device that is the subject of this report were provided by the customer.Examination of the supplied photographs shows unidentified foreign matter within the packaging of the device.A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.It should be noted there were no other reported complaints for this lot number.Based on the information provided, examination of the supplied photographic images and the results of our investigation, the event is related to a manufacturing deficiency.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: COOK AIRWAY EXCHANGE CATHETER
• Common Device Name: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6727877
• Report Number: 1820334-2017-01760
• Device Sequence Number: 881673
• Product Code: LRC
• UDI-Device Identifier: 00827002058804
• UDI-Public: (01)00827002058804(17)200314(10)7748069
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2017

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?: No
• Operator of Device: No Information
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-19.0-83
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1