MAUDE Adverse Event Report: COOK INC COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER; LRC CHANGER, TUBE, ENDOTRACHEAL

Catalog Number	C-CAE-11.0-100-DLT-EF-ST
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/17/2018
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, hair-like fiber, was found inside the sterile packaging of a cook double lumen extra firm soft tipped airway exchange catheter.As reported, this 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.Device evaluation: one unused device was returned in original packaging.A brown/orange fiber was found on the distal end of the catheter packaging.No other surface damage or foreign matter was observed.Investigation: a document-based investigation reviewed the following: review of device history record, review of ifu, review of qc.A review of the device history record revealed no related non-conformances.A complaint history review revealed no additional complaints have been reported for this failure and lot combination.From the document review, it has been found that there are sufficient controls in place to detect foreign matter prior to release to the customer.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.Conclusion: from the review of the device master record, the root cause is possibly manufacturing deficiency, specifically in quality control.There are checks in place to catch this failure before it is released to the customer, and risk documents providing adequate risk controls in place.There is no evidence that there are nonconforming product from this lot in the field or house, and there is no evidence that the device was manufactured out of specification.Nevertheless, the appropriate personnel have been notified of this incident.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER
• Common Device Name: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8061639
• Report Number: 1820334-2018-03259
• Device Sequence Number: 1458977
• Product Code: LRC
• UDI-Device Identifier: 00827002364011
• UDI-Public: (01)00827002364011(17)210720(10)9034224
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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: 07/20/2021
• Device Catalogue Number: C-CAE-11.0-100-DLT-EF-ST
• Device Lot Number: 9034224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1