MAUDE Adverse Event Report: COOK INC THREE-WAY PLASTIC ROTATING ADAPTER STOPCOCK; KGZ ACCESSORIES, CATHETER

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event Description

It was reported that the product is leaking when cytostatica is given to the patient.When they first flush the device with saline, there is no leakage, however, when cyto is given to the patient, the device starts to leak.A section of the device did not remain inside the patient¿s body.The patient required additional procedures due to this occurrence.As cc form: they used another device from another supplier.

Manufacturer Narrative

No physical evaluation could be performed since the device was not returned.However, a document-based investigation was performed.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconformances which would contribute to this failure mode.There were no other reported complaints for this lot number.Without a returned product to evaluate, a definitive root cause is unable to be confirmed.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Outcomes attributed to ae should be blank because this is not an adverse event.(b)(4).

• Brand Name: THREE-WAY PLASTIC ROTATING ADAPTER STOPCOCK
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6121603
• MDR Text Key: 60686999
• Report Number: 1820334-2016-01407
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002012035
• UDI-Public: (01)00827002012035(17)210721(10)NS7137451
• Combination Product (y/n): N
• Reporter Country Code: SE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1PTWS-RA-R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Date Device Manufactured: 07/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other