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

Catalog Number	C-AEBS-5.0-50-SPH-AS
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).510k -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
The international customer reported prior to patient contact the arndt endobronchial blocker set was noted to have a foreign object in the sterile packaging.The product and packaging has been received for evaluation and investigation; however, the investigation is still in progress at the time of this report.
Additional Manufacturer Narrative
Investigation/evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and visual inspection of the device was conducted during the investigation.One unopened c-aebs endobronchial blocker set was returned.A small, brown, unidentified piece of foreign matter was present in the sealed package.Foreign matter has been confirmed additionally, a document based investigation was performed.A review of the device history record for lot number 7853565 revealed no notable non-conformances related to the reported failure mode.A search of our complaint management system revealed this to be the only reported complaint from lot number 7853565.Each device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.C_t_aebs_rev.3 [arndt endobronchial blocker set] states: "how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Do not use the product if there is doubt as to whether the product is sterile.Upon removal from package, inspect the product to ensure no damage has occurred." it is reasonable to suggest that foreign matter was introduced during the manufacturing process before the device's package was sealed.The cause of this is manufacturing related.This failure mode is being escalated per internal processes.We will continue to monitor for similar complaints and have notified the proper personnel about this event.Per the quality engineering risk assessment no further action is required.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: 7397980
• Report Number: 1820334-2018-00861
• Device Sequence Number: 113866
• Product Code: CBI
• UDI-Device Identifier: 00827002441095
• UDI-Public: (01)00827002441095(17)200424(10)7853565
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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 Catalogue Number: C-AEBS-5.0-50-SPH-AS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1