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

Catalog Number	C-UTLMY-501J-RSC-CCT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) #: 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 a triple lumen polyurethane central venous catheter (cvc) was placed in the right internal jugular on (b)(6) 2018 for a pericardial effusion.The blue hub was found cracked on (b)(6) 2018.The patient required an additional procedure to remove and replace the device."the customer mentioned the issue of over tightening and it was pointed out by the hospital staff that is always the blue lumen that is cracking." the device was used to deliver continuous, scheduled and one time dose medications.The line was flushed with heparin as needed.As reported, the patient did not experience any other adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Device evaluation the reported device was not returned to cook inc.For evaluation nor were unused devices from the same lot.Investigation a document-based investigation reviewed the following: instructions for use, quality control, specifications, complaint history, device history records and manufacturing instructions.A review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.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.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 our investigation, a definitive root cause cannot be determined at this time.Per the [quality engineering] risk assessment, no further risk reduction action is required however appropriate measures have been initiated to investigate this failure mode.Monitoring will continue to be performed for similar complaints.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.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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.

• 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: 7741037
• Report Number: 1820334-2018-02226
• Device Sequence Number: 1050207
• Product Code: DQY
• UDI-Device Identifier: 00827002269453
• UDI-Public: (01)00827002269453(17)191101(10)8564700
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2018
• 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-RSC-CCT
• Device Lot Number: 8564700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 11/28/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 11/21/2018; 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: A CAREFUSION SMARTSITE 2000E
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Date Report Sent to FDA: 09/25/2018