MAUDE Adverse Event Report: CLINICAL INNOVATIONS KIWI OMNICUP; KIWI VACUUM DELIVERY SYSTEM, OMNICUP

Model Number	VAC-6000ME
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if an injury occurred.A 15 minute delay may result in an injury to the infant.It is highly unlikely we are getting the sample.A supplemental will be filed for any additional update or information.
Event or Problem Description
The cables inside the flexion unit got broken during traction.No consequences for patient or baby but a delay of 15 min was reported.No further information was reported.No sample.
Additional Manufacturer Narrative
Please see the following investigation completed on this returned device.Device history lot review: the device history record review has been performed on lot 181003.No ncr or deviation was found.This lot met all the specifications outlined for release of the product.Sample analysis: a visual inspection was performed on the returned device on the complaint related to the cables inside the flexion tube that broke during traction.A visual inspection was performed on this device and confirmed that the cable was broken inside.Functionality test cannot be performed because the cable was broken.The device was dismantled to check the cause for the cable to break during use.In the product evaluation, it was found that the cable was broken at the crimp sleeve inside the handle.The cable from the crimp sleeve can be visible from one side and outer side was broken at the exact position where the cable was snapped on the crimp sleeve.The cup was investigated and no symptoms of plastic deformation to state that the user had applied more traction force than suggested that leads to a cable that breaks.The cable sleeve inside the device was corroded.Conclusion: the reported complaint is confirmed.This complaint will now be closed.A letter will be sent on the findings of this investigation.
Event or Problem Description
No report of any injury to either the mother or the baby.Sample has been returned.

• Brand Name: KIWI OMNICUP
• Common Device Name: KIWI VACUUM DELIVERY SYSTEM, OMNICUP
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8661101
• Report Number: 1722684-2019-00012
• Device Sequence Number: 2274653
• Product Code: HDB
• UDI-Device Identifier: 00814247020000
• UDI-Public: 00814247020000
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2020
• Device Model Number: VAC-6000ME
• Device Lot Number: 181003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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