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	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) # pre-amendment.Patient code: no code available ((b)(4)) catheter removed additional procedure for new line placement.This report contains relevant information known at this time.If relevant additional information becomes available a follow-up will be submitted accordingly.
Event or Problem Description
It was reported a central line was placed on (b)(6) 2018 at 0545am utilizing a 5fr triple lumen polyurethane central venous catheter (cvc).On (b)(6) 2018, the fluid was found to be leaking from the cracked blue hub.As a result the catheter had to be removed and another central line was placed.It was further stated there is "the possibility that individuals are screwing the end caps on too tight".No further patient consequences have been reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Investigation evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The complaint device was returned for evaluation.Visual inspection found no kinks or damage, however, a crack was found on the blue hub.During a leak test, the blue hub failed immediately.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 no 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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually and functionally inspected by quality control and no notable gaps in production or processing controls were noted.The risk specification for this product includes the hub fracture failure mode and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.Per the [quality engineering] risk assessment, no further action is required.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.
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.
Event or Problem Description
An sus voluntary report, mw5080167, was received on 25oct2018 and reconciled with this case.The final report submitted on 27jun2018 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: 7680514
• Report Number: 1820334-2018-02094
• Device Sequence Number: 1553491
• Product Code: DQY
• UDI-Device Identifier: 00827002269415
• UDI-Public: (01)00827002269415(17)200321(10)8642521
• 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): 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: 03/21/2020
• Device Catalogue Number: C-UTLMY-501J-CCT
• Device Lot Number: 8642521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 10/25/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/25/2018; 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
• Date Report Sent to FDA: 09/25/2018