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

Catalog Number	MCIS-5.0-35-130-20.0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: weigao 0.35 loach wire guide, weigao 10ml injection syringe.Pma/510(k) number: 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
It was reported, a multi-sideport dual check valve catheter infusion set was utilized for treatment of phlebothrombosis (blood clot not associated with inflammation).A thrombolysis procedure whereby urokinase and heparin were being infused through the sideport's to dissolve the clot was underway when a leak was noted coming from the connection of the y valve.A power injector was not in use.No resistance was encountered upon insertion or removal of this device.The physician replaced the complaint device with a second multi-sideport dual check valve catheter infusion set from the same lot and this device leaked as well.The procedure was able to be completed using another manufacturer's device.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.According to the complainant, only one multi-sideport dual check valve catheter infusion set will be returned to aid the manufacturer's investigation.
Additional Manufacturer Narrative
Investigation evaluation: a review of the complaint history, device history record, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one (1) used mcis-5.0-35-130-20.0 set was returned for investigation.The following was included in that return: wire inserted through the catheter, 10 ml syringe, and a tuoghy-borst sidearm with rotating male.Leakage was noted at the y-fitting main body (female luer arm) and no other parts of the device leaked.The wire and catheter were returned with no visible damage.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 showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions, drawing, and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8047531
• Report Number: 1820334-2018-03322
• Device Sequence Number: 11078401
• Product Code: DQO
• UDI-Device Identifier: 00827002087040
• UDI-Public: (01)00827002087040(17)181011(10)6245012
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: 10/11/2018
• Device Catalogue Number: MCIS-5.0-35-130-20.0
• Device Lot Number: 6245012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 61