MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number N/A

Device Problem Disconnection (1171)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested and not yet received.The event is currently under investigation.

Event Description

It was reported that during an unspecified procedure using a performer introducer, as the nurse was flushing the equipment (attaching a leur lock syringe to hub) and the hub connection broke off.It was also reported the device was handled with contaminated gloves.It was reported that the device broke prior to use/patient contact.

Manufacturer Narrative

Investigation methods included a review of the complaint history, device record history, documentation, drawing, instructions for use (ifu), manufacturing instructions (mi) and quality control (qc).Numerous quality control, design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.The device nor a lot number information was provided, a search of the device history record was unable to be performed, in an effort to determine if any non-conformance within the manufacturing department was noted.If new information becomes available the complaint will be updated.There is no evidence to suggest that product was not manufactured to current specifications.Based on the limited information provided regarding the case, a definitive root cause could not be determined.No adverse effect to the patient was reported.

• Brand Name: PERFORMER INTRODUCER
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6503489
• MDR Text Key: 73235545
• Report Number: 1820334-2017-00799
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: RCFW-16.0P-38-45-RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1