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	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the blue hub of the triple lumen polyurethane central venous catheter was found cracked on (b)(6) 2018 at 0100.The device was initially placed on (b)(6) 2018 to deliver medications and parenteral nutrition.According to the initial reporter, the device was attached to a smartsite needle free valve at the time the crack was observed.It was reported that 70 percent (%) alcohol swab was used and allowed to completely dry before placing a new needleless connector (nc).Prior to observing the crack in the blue hub on (b)(6) 2018, needleless connector changes had occurred daily, with the most recent at (b)(6) 2018 at 2100.The patient was unable to receive parenteral nutrition for twenty (20) hours due to the loss of one lumen and issues with compatibility of other medications being infused in the remaining lumens.The customer provided that this did not have a long term impact on the patient.The device was removed and replaced during a second procedure using an alternative access site.
Event or Problem Description
There has been no new event information received.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history records, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one 5fr triple lumen catheter to cook for investigation.Visual inspection of the device concluded that there were no noted kinks to the device.Biomatter was present mostly inside and also on the outside of the tubing, and the blue clamps have slightly crimped the extension tubes.All lumens were returned with non-cook needle-less connectors.A leak test was performed on all hubs.The blue hub leaked and visual inspection confirmed that the blue hub had a crack.Light blue stress marks were noted on the right side above and below the hub's wing.Cavity number of the hub was 3.The crack was opposite the gate (the crack was confirmed along the weld line).The white hub did not leak and visual inspection confirmed that there was no damage to the hub.Liquid was present in the extension tube.The red hub did not leak and visual inspection confirmed that there was no damage to the hub.A tug test was performed and it was confirmed that all connections between the lumen, the suture wing, and hubs was secure.Investigators could recreate the reported failure mode.A review of the dhr for lot 8905297 (complete set, subassemblies, and raw materials) records no non-conformances that would cause or contribute to the reported failure mode.A complaint search of lot 8905297 and all of its sub-assemblies, raw materials, and components revealed 6 complaints with a similar failure.As this is a known failure mode with an open investigation, it is expected that overlapping sub-assemblies and their respective raw materials would occur.There is no information stating how the device was secured to the patient to prevent inadvertent tension on the hub.There is no information regarding the patient environment (e.G., bed rails, bedding, other medical devices) that may have caused iv lines to become entangled, resulting in unnecessary pulling on the hub.There is no information regarding patient¿s cognition, behavior or safety awareness that may have led to inadvertent pulling on the hub.There is no information regarding application of the smartsite or if the device met its manufacturing quality specifications.It is not known how the smartsite devices were connected or tightened.At this time, the clinical assessment cannot eliminate any possible causes for this event such as product handling, other device compatibility, device maintenance, patient safety awareness, patient environment, device failure, or manufacturing related causes.The complaint was confirmed based on the returned device.A definitive conclusion could not be established.Measures have been initiated to address this failure mode.The supplier is supporting cook inc.In this process.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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: 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: 8085868
• Report Number: 1820334-2018-03260
• Device Sequence Number: 1620616
• Product Code: DQY
• UDI-Device Identifier: 00827002269415
• UDI-Public: (01)00827002269415(17)200323(10)8905297
• 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
• Report Date (Section B): 03/18/2019

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: 03/23/2020
• Device Catalogue Number: C-UTLMY-501J-CCT
• Device Lot Number: 8905297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 03/18/2019
• 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: NEEDLELESS VALVE ; NEEDLELESS VALVE
• Outcome Attributed to Adverse Event: Other