MAUDE Adverse Event Report: 10007LP MITYVAC M-STYLE CUP

Model Number	10007LP
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).
Event or Problem Description
I would like to report that the cup was ruptured during vacuum delivery operation.The device was changed to the new one, then procedure was completed.Baby had a abrasion on head.
Additional Manufacturer Narrative
Distribution history: the 53348 mityvac m-style cup assembly was purchased from carclo technical plastics, received at csi 7/25/2017, issued to work order.236058 as csi part number 10007lp and completed 11/30/2017.Manufacturing record review: the dhr for this unit was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: a review of the incoming inspection record was performed and not that the receipt was acceptable.Service history record : service history record not applicable to this product.Historical complaint review: a review of the product two-year history indicated did not reveal any trends related to the description of the reported event.The reported event will be monitored for possible future reported event trending.Product receipt: the sample was not returned at the time of this investigation.Visual evaluation: the sample was not returned at the time of this investigation.Functional evaluation: functional evaluation is not applicable to this complaint.Root cause: the root cause of the reported event is definitively indeterminable.A review of the photos provided with the complaint indicate a typical tearing of the over-molded rubber compound, this is in-line with a potential overstressed material during use, or the material being compromised or punctured.This reported event would indicate a result attributed to an action or event after the device had been shipped from the csi fg warehouse as each device is visually verified and functionally tested before packaging.A review of the lot dhr did not reveal any abnormality, see attached.A review of the manufacturing process was noted to be in-control, and unaltered.Inventories of the affected lot 236058 as reported were depleted and not available for further verification at csi trumbull fg warehouse.Further evaluation for continuous improvements will be performed, and any feasible or required assembly process improvement.
Event or Problem Description
It was reported that the cup was ruptured during the vacuum delivery operation, the device was replaced, then the procedure was completed.Baby had abrasion on the head.Mityvac m-style cup 10007lp (b)(4).

• Brand Name: MITYVAC M-STYLE CUP
• Common Device Name: MITYVAC M-STYLE CUP
• Manufacturer (Section D): 10007LP; endeavour medical; unit 2; 9 kellaway place, wetherill park CT NSW 2 164; AS NSW 2164
• Manufacturer (Section G): COOPER SURGICAL, INC; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 8424990
• Report Number: 1216677-2019-00130
• Device Sequence Number: 198486
• Product Code: HDB
• UDI-Device Identifier: 00888937003048
• UDI-Public: 888937003048
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K890307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2020
• Device Model Number: 10007LP
• Device Catalogue Number: 10007LP
• Device Lot Number: 236058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown