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

Catalog Number	C-UDLMY-501J-PED-CCT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(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 double lumen polyurethane central venous catheter (cvc) was found leaking at the blue hub less than one hour after placement.The patient required an additional line replacement procedure.As reported, the patient did not experience any additional adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, as well as functional test and visual inspection of the returned device was conducted during the investigation.One central venous double lumen catheter was returned for investigation in used condition.An unknown cap was found to be attached to the blue hub.Biomatter was present on the manifold, white hub, blue hub and inside both extension tubes, with the heaviest amount of biomatter concentrated within the blue hub.No additional damage was noted to the catheter aside from the crack in the hub.The blue hub is from cavity number one, with the gate on the wing opposite from the crack.The crack is in line with one of the wings and measured 6mm.The white lumen is slightly occluded, but water could be forced through when pressure was applied.Leakage was found to be coming from the crack in the blue hub during the functional test.The hubs were noted to be securely fitted to the lumens.From the description of the device failure analysis, it was concluded that the failure occurred on the weld line.Additionally, a document based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Precautions noted in the instructions for use (ifu) advise the user to not re-sterilize the product, cut, trim or modify the catheter or components prior to placement or intraoperatively.The product should be stored in a dark, dry, cook place, as extended exposure to light should be avoided.The product should be inspected by the user prior to use to ensure that no damage has occurred.A review of the device history record showed no relevant nonconformances that could have contributed to this failure mode.It should be noted that no other complaints were found for the main and subassembly lots.Inspection for raw material lots were reviewed, and all lots found to be ¿ok¿.It was concluded that there is no evidence that nonconforming product exists in house or in the field.The investigation found that the affected component of the device is supplied from an external supplier, and an investigation was conducted by the supplier at the request of cook.The supplier¿s description of the failure mode assumed the crack was located along the weld line as in other cracked hub reports, as the weld of the hub is the weakest feature.If the male luer fitting is over engaged in the female luer taper of the hub, the weld line can be prone to cracking due to excessive force.Manufacturing logs of hub lots were reviewed, and no anomalies were noted in the manufacturing process.No nonconforming product has been identified in house of in the field.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could not be established.Appropriate measures have been taken to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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
No new event description information to report at this time.

• Brand Name: DOUBLE 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: 7922518
• Report Number: 1820334-2018-02757
• Device Sequence Number: 19242377
• Product Code: DQY
• UDI-Device Identifier: 00827002269361
• UDI-Public: (01)00827002269361(17)200321(10)8638120X
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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: 03/21/2020
• Device Catalogue Number: C-UDLMY-501J-PED-CCT
• Device Lot Number: 8638120X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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