MAUDE Adverse Event Report: COOK INC ARNDT ENDOBRONCHIAL BLOCKER SET; CBI TUBE, TRACHEAL/BRONCHIAL

Catalog Number	C-AEBS-5.0-65-SPH-AS
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k160542.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 that a hair was identified in the sterile packaging of a arndt endobronchial blocker set, prior to use on the patient.Additional event information has been requested but not yet provided.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Device evaluation: the reported unused sealed complaint device was returned to cook inc.For evaluation.Visual inspection confirmed the report of foreign matter as a brown filament was identified inside the package near the blue extension tube hub.Investigation: a document-based investigation reviewed the following: instructions for use, quality control, specifications, complaint history, manufacturing instructions and device history record.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.Conclusion: additional investigation activities related to quality control were performed during the productions of this lot.As a result of this activity, new gowning procedures have been implements to prevent this failure.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed 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.

• Brand Name: ARNDT ENDOBRONCHIAL BLOCKER SET
• Common Device Name: CBI TUBE, TRACHEAL/BRONCHIAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8153517
• Report Number: 1820334-2018-03462
• Device Sequence Number: 16587057
• Product Code: CBI
• UDI-Device Identifier: 00827002441118
• UDI-Public: (01)00827002441118(17)191214(10)7519768
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: No Information
• Device Expiration Date: 12/14/2019
• Device Catalogue Number: C-AEBS-5.0-65-SPH-AS
• Device Lot Number: 7519768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1