MAUDE Adverse Event Report: COOK INC OPEN-END URETERAL CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	020015
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 an eyelash was observed inside the sterile package of a ureteral catheter prior to opening the pouch.This packaging anomaly was detected prior to use; therefore, no patient contact.
Additional Manufacturer Narrative
Investigation/evaluation: the investigation performed for this complaint report included a review of complaint history, the device history record, and specifications.A visual inspection of the returned device was also conducted during the investigation.One open package rpn 020015, label lot number 8373504 was received.Visual examination confirms a hair in the sealed package.The device history record was reviewed and noted there were no related non-conformances during the manufacturing process.A review of complaint history revealed this is the only reported complaint associated to complaint lot number 8373504.Based on the evidence presented by the sample, the cause of this complaint is likely manufacturing related.Additional measures have been initiated to address this failure mode.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.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: OPEN-END URETERAL CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7371771
• Report Number: 1820334-2018-00705
• Device Sequence Number: 13470273
• Product Code: DQO
• UDI-Device Identifier: 00827002142749
• UDI-Public: (01)00827002142749(17)201114(10)8373504
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: No Information
• Device Catalogue Number: 020015
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1