MAUDE Adverse Event Report: COOK INC SINGLE LUMEN CENTRAL VENOUS CATHETER SET; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
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
International customer reported that a patient underwent placement of a single lumen central venous catheter.The customer states that the device did not seal with a three-way stopcock or needleless injection caps.The physician used an additional extension tube to accomplish a seal with the devices.There are no reported adverse patient consequences.The device is available for evaluation.
Additional Manufacturer Narrative
Pma/510(k): preamendment.Investigation summary: a review of the complaint history, device history record, instructions for use(ifu), specifications, and visual inspection of the returned device were conducted during the investigation.One used device and one set was returned for investigation.The three-way stopcock that was in question was not returned for investigation.Used device- the returned catheter length measured 2 cm.A leak test was conducted on the catheter using a hemostat and a one-way stopcock.No leaks were noted.The returned connecting tube was also checked and no leaks were noted.Unused device-the unused catheter length measured 5 cm.A leak test was conducted on the catheter using a hemostat and a one-way stopcock.No leaks were noted.The returned connecting tube was also checked and no leaks were noted.Since the three-way stopcock that the customer had questioned was not returned, an investigation to determine the effects of the use of the three-way stopcock could not be evaluated.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 device lot number.It should be noted there were no other reported complaints for this lot number.Since the three-way stopcock that the customer had questioned was not returned, an investigation to determine the effects of the use of the three-way stopcock could not be evaluated.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; 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.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause cannot be determined.The quality engineering risk assessment for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.The appropriate personnel will be notified and we will continue to monitor for similar complaints.

• Brand Name: SINGLE LUMEN CENTRAL VENOUS CATHETER SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6684661
• Report Number: 1820334-2017-01624
• Device Sequence Number: 13945735
• Product Code: DQY
• UDI-Device Identifier: 00827002031203
• UDI-Public: (01)00827002031203(17)190929(10)7317058
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PUM-301J-PED
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1