MAUDE Adverse Event Report: COOK INC MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	MCIS-5.0-35-130-15.0
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the initial reporter, the device will not be returned.Pma/510(k) number = preamendment (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 that during inspection of the multi-sideport dual check valve catheter infusion set, it was observed that there was a hair inside of the primary package.The device was not used and did not come into contact with a patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, quality control, and specifications of the device as well as a photographic inspection were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, the customer returned photographs of the complaint device.The presence of hair-like foreign matter was confirmed via the inspection of the returned photographs.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7305829
• Report Number: 1820334-2018-00638
• Device Sequence Number: 2379428
• Product Code: DQO
• UDI-Device Identifier: 00827002064256
• UDI-Public: (01)00827002064256(17)190923(10)7267356
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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: MCIS-5.0-35-130-15.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1