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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/26/2017
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
Prior to the opening of the package, it was observed that the tip of the syringe in the arndt endobronchial blocker set was "broken and missing" (sic).The product issue was discovered prior to use; accordingly, no patient adverse events resulted from the product malfunction.The product was returned for evaluation; however, as of the date of this report the investigation is still pending.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control data, specifications, and visual inspection of the device was conducted during the investigation.One unopened and unused product was returned to assist with this investigation.Examination of the device observed the tip of the syringe to be missing in the sealed tray.The tip of the syringe was not located in the tray.¿ because the tip of the syringe could not be located, and the returned product was unopened and unused, it is reasonable to suggest this failure was manufacturing related.Additionally, a document based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Although the proper manufacturing documents are in place at cook inc., it is reasonable to suggest that the defective syringe was one of the products that were not sampled during level i incoming inspection, making it through to the packaging department where the syringes are placed in the trays.Because of the small size of the tip of the syringe and the high quantity of syringes being placed in trays, it is reasonable to suggest the prepper or qc inspector did not see the defect in the tip of the syringe before it was shipped.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined to be ¿manufacturing related ¿ process related¿.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.

• 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: 7017955
• Report Number: 1820334-2017-03793
• Device Sequence Number: 11025697
• Product Code: CBI
• UDI-Device Identifier: 00827002269071
• UDI-Public: (01)00827002269071(17)180611(10)5950212
• Combination Product (Y/N): N
• PMA/510(K) Number: K002288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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-AEBS-7.0-65-SPH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1