MAUDE Adverse Event Report: COOK INC COOK TPN SINGLE LUMEN CATHETER REPAIR SET; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/12/2017
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 international customer reported that the cook tpn single lumen catheter repair set failed to repair the patient's central venous catheter and broke.The circumstances surrounding the handling and usage of the device are not known.Additional information has been requested from the customer.The product is reportedly unavailable for return.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint device, device history record, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation, and no issues were found related to the reported issue.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 five other reported complaints for this lot number.The cook tpn single lumen catheter repair set is shipped with instructions for use: (ifu), which clearly state the proper warnings, precautions, and instructions for use with each device.Specifically; ¿care should be taken when using a wire guide through a cook tpn catheter repair set to prevent damage with-in the catheter.Firmly clamp the catheter near its entrance to the skin with rubber-shod forceps.The stylet acts as a guide for insertion of the metal cannula.After insertion of the metal cannula into the lumen of the existing catheter, the stylet should be removed¿.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not 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: COOK TPN SINGLE LUMEN CATHETER REPAIR SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7018371
• Report Number: 1820334-2017-01725
• Device Sequence Number: 1394116
• Product Code: DQY
• UDI-Device Identifier: 00827002018686
• UDI-Public: (01)00827002018686(17)180509(10)7910528
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-RHCS-4.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 02/07/2018
• 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
• Patient Age: 2 YR