MAUDE Adverse Event Report: KENTEC MEDICAL KIWI PROCUP VACUUM DELIVERY SYSTEM; VACUUM CUP

Model Number VAC-6000S

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

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

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) is not the manufacturer of the device.(b)(4) is a distributor only for the device.The manufacturer of the device is clinical innovations, est (b)(4).A copy of original user report # mw5062188 will be provided to the manufacturer.

Event Description

As per report # mw5062188 received 6/9/2016 via postal mail from fda: unknown customer facility submission of product malfunction for product model vac-6000s manufactured by clinical innovations.(b)(4) is not the manufacturer of this device.(b)(4) is a distributor only for this device.

• Brand Name: KIWI PROCUP VACUUM DELIVERY SYSTEM
• Type of Device: VACUUM CUP
• Manufacturer (Section D): KENTEC MEDICAL; 17871 fitch; irvine CA 92614
• Manufacturer (Section G): CLINICAL INNOVATIONS; 747 west 4170 south; murray UT 84123
• Manufacturer Contact: keith rooks ; 17871 fitch; irvine, CA 92614 ; 9498630810
• MDR Report Key: 5717150
• MDR Text Key: 48152494
• Report Number: 2080225-2016-00001
• Device Sequence Number: 1
• Product Code: HDB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAC-6000S
• Device Catalogue Number: VAC-6000S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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