MAUDE Adverse Event Report: CLINICAL INNOVATIONS KIWI OMNICUP; KIWI VACUUM DELIVERY SYSTEM, OMNICUP WITH TRACTION FORCE INDICATOR

Catalog Number	VAC-6000MTE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Edema (1820); Swelling (2091); Injury (2348)
Date of Event	05/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are in the process of gathering information.A supplemental will be filed.
Event or Problem Description
An incident has been reported that occurred in (b)(6): laying a kiwi sucker during a delivery, then traction and progression of the head.Release of the suction cup.Second insertion of the sucker, progression of childbirth then observation of the purplish and edematous left eye.Decision to remove the suction cup.Confirmation of a bruise and edema in the left eye fusing at the level of forehead and at the base of the nose.Slight right eye edema without bruise.New information reported: we are following this case very closely, at this stage the lesion seems not too severe and the baby recovers well.
Event or Problem Description
New information has been received on this incident.The customer confirmed wrong use of the cup.The facility followed the case closely and at this stage the lestion seems not too severe and the baby recovers well.The lot used is unknown and the device discarded.
Additional Manufacturer Narrative
We have completed our investigation.: device history record review: a dhr cannot be performed.The customer has not provided any information on the lot#.If clinical innovations receives any update, a lot review will be performed.Sample analysis: no sample has been returned.Root cause analysis.No device was returned to investigate the cause for a device failure.But, the customer has confirmed that the incident occurred due to wrong use of device.This concludes that the root cause is user error-user has not followed instructions specified in the ifu.Conclusion: no investigation can be performed because the lot is unknown, and no device was returned to perform testing.We are unable to confirm this complaint.The root cause is not determined at this time since no sample was returned.A letter has been provided to the facility of these findings.The facility has been encouraged to save any product in question for any future incidents.

• Brand Name: KIWI OMNICUP
• Common Device Name: KIWI VACUUM DELIVERY SYSTEM, OMNICUP WITH TRACTION FORCE INDICATOR
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8732003
• Report Number: 1722684-2019-00014
• Device Sequence Number: 2572699
• Product Code: HDB
• UDI-Device Identifier: 00814247020659
• UDI-Public: 00814247020659
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VAC-6000MTE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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: Other