MAUDE Adverse Event Report: DEPUY CMW 9610921 CRV MINI KAMVAC SUCTION TUBE; ENVIRONMENTAL PROTECTION AND MISC

Catalog Number	530020500
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the foreign materials were found.This issue was found during incoming inspection.Update oct 6, 2017 -- product follow-up determined that the foreign material was inside the sterile packaging.Reportability decision modified.Complaint updated on : oct 20, 2017.
Additional Manufacturer Narrative
Examination of the returned product packaging identified the item conforms to specification.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CRV MINI KAMVAC SUCTION TUBE
• Common Device Name: ENVIRONMENTAL PROTECTION AND MISC
• Manufacturer (Section D): DEPUY CMW 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 6967773
• Report Number: 1818910-2017-27201
• Device Sequence Number: 444756
• Product Code: JOL
• UDI-Device Identifier: 10603295171515
• UDI-Public: 10603295171515
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 530020500
• Device Lot Number: 53195437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 10/22/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1