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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that the blue lumen portion of a double lumen polyurethane central venous catheter was leaking after implantation.The customer confirmed that only the blue lumen was affected, as the white lumen did not leak when used.The customer had concerns regarding potential contamination.Another central line needed to be placed.The product is reportedly available for return.
Additional Manufacturer Narrative
Corrected information: report source: health professional, user facility, company representative.Investigation summary: a review of the dimensional verification, device history record, complaint history, specifications, drawings, quality control data, instructions for use(ifu), functional testing and visual inspection of the returned device were conducted during the investigation.The device was returned in used condition, with microclaves still attached to the hubs.The leak test was inconclusive; there was an occlusion, so no leakage was observed with and without the microclaves.The catheter was otherwise undamaged.The outer diameter of the blue tubing was also within specification.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no other non-conformances associated with the complaint failure mode.It should be noted there were no other reported complaints for this lot number.An occlusion in the blue line was found during testing.If the occlusion occurred during the insertion process, it is feasible that the leak was the result of back flow from the occluded line.However, without knowing when the occlusion occurred, it is not possible to definitively state that the occlusion was the contributory cause for this failure.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6835069
• Report Number: 1820334-2017-02739
• Device Sequence Number: 11117647
• Product Code: DQY
• UDI-Device Identifier: 00827002269279
• UDI-Public: (01)00827002269279(17)190901(10)7727526
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UDLMY-401J-CCT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 12/13/2017
• 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: MEDICATIONS/INFUSIONS
• Outcome Attributed to Adverse Event: Required Intervention