MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: pre-amendment.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
As reported, what appeared to be a piece of dark hair was discovered during quality inspection by a distribution center inside the sealed ultrathane mac-loc locking loop biliary drainage catheter package.This device was discarded and did not reach facility or patient.As reported, the product did not reach patient, therefore there were no adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Investigation evaluation.A review of the complaint history, device history record, instructions for use (ifu), and quality control was conducted during the investigation.The product was not returned to aid in the investigation.The user facility did provide images of the complaint device, showing visible foreign matter in the sealed package which confirms customer testimony.A document review was also conducted during the investigation.It should be noted there are no relevant non-conformances for lot #8781601.As there is no evidence of similar related non-conformances, the investigation has concluded that adequate inspection activities have been established.Additionally a review of complaints from the same lots and found no other reported complaints associated with the lots.There is no evidence that nonconforming product exists in house or in the field.Based on the results of the investigation and the available information, the root cause can be traced to manufacturing and is likely a quality control deficiency.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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.
Event or Problem Description
No additional information has been added to the event description since the previous medwatch report was submitted.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Common Device Name: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8199920
• Report Number: 1820334-2018-03766
• Device Sequence Number: 1699146
• Product Code: GCA
• UDI-Device Identifier: 00827002094987
• UDI-Public: (01)00827002094987(17)210418(10)8781601
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/14/2019

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: 04/18/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Device Lot Number: 8781601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1