MAUDE Adverse Event Report: COOK INC AQ URETERAL DILATOR; KOE DILATOR, URETHRAL

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	05/25/2017
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
It was reported that prior to performing an unspecified procedure, the customer opened the package containing an aq ureteral dilator and found a hair inside.The customer further stated that the hair appeared to be embedded in the hydrophilic coating.The device did not come in contact with the patient and there was no patient harm reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of device history record, complaint history, documentation, specifications and instructions for use (ifu) was conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and no non-conformances were identified.A thorough review of complaint history search revealed that this is the only recorded complaint associated with this lot number based on the information provided the likely root cause is related to manufacturing deficiency and the presence of foreign matter.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: AQ URETERAL DILATOR
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6654039
• Report Number: 1820334-2017-01530
• Device Sequence Number: 1150501
• Product Code: KOE
• UDI-Device Identifier: 00827002176362
• UDI-Public: (01)00827002176362(17)191116(10)7448601
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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 Model Number: N/A
• Device Catalogue Number: AQ-076012-TP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 11/08/2017
• Patient Sequence Number: 1