MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER TRAY; DQY CATHETER, PERCUTANEOUS

Catalog Number	C-UTLMY-501J-CCT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: carefusion smartsite 2000e needleless connector.Pma/510(k) #: pre-amendment, (b)(4).Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual/functional inspection of the returned device was conducted during the investigation.The reported device was returned for evaluation.There were no major kinks noted on the catheter nor damage to the catheter/suture wing or hubs.The catheter was curved indicating use.Visual inspection identified a 7mm crack on the blue hub which leaked immediately during a leak test.All diameters and tubing lengths were within specification and the lumen of the device was not occluded.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows zero nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided and the results of the investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.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 triple lumen polyurethane central venous catheter was placed intra-operatively during a right internal jugular arterial switch procedure on (b)(6) 2018.On (b)(6) 2018, a crack was identified on the catheter.The patient was receiving iv medications and continuous fluids.As reported, the patient required another central line to be placed with a new puncture site, however, did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
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.- attachment: [mw5080167.Pdf].
Event or Problem Description
A sus voluntary report, mw5080167, was received on 25oct2018 and reconciled with this case.The investigation reported on 21aug2018 remains unchanged.

• Brand Name: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER TRAY
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7800660
• Report Number: 1820334-2018-02218
• Device Sequence Number: 13935103
• Product Code: DQY
• UDI-Device Identifier: 00827002269415
• UDI-Public: (01)00827002269415(17)191101(10)8548839
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018
• Report Date (Section F): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: C-UTLMY-501J-CCT
• Device Lot Number: 8548839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 MO
• Date Report Sent to FDA: 09/25/2018