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

Catalog Number	C-UTLM-901J-RSC
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: preamendment.Patient code: no code available - additional procedure required to replace cracked device.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 triple lumen polyurethane central venous catheter was placed in the subclavian and presented a crack in the tip three days after placement.This crack resulted in a leak.As reported, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional information: the customer reported that the device was infusing simple ringer serum and the maintenance protocol was reportedly 10 ml/hour, to maintain deep venous access permeability.Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted 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 inspected by quality control and no notable gaps in production or processing controls were noted.The risk specification for this product includes the catheter 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, no product returned and the results of our investigation, a definitive root cause could not be established.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7834956
• Report Number: 1820334-2018-02598
• Device Sequence Number: 1337639
• Product Code: DQY
• UDI-Device Identifier: 00827002128644
• UDI-Public: (01)00827002128644(17)210112(10)NS8460468
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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 Expiration Date: 01/12/2021
• Device Catalogue Number: C-UTLM-901J-RSC
• Device Lot Number: NS8460468
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR