MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CBC II KIT WITH 3/16" ROUND PVC WOUND DRAIN; APPARATUS, AUTOTRANSFUSION

Catalog Number	0225426000
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device's vacuum stopped working during a procedure.Approximately 100ml of blood was collected.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.
Additional Manufacturer Narrative
The reported event was duplicated.
Event or Problem Description
The user facility reported that the device's vacuum stopped working during a procedure.Approximately 100ml of blood was collected.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.

• Brand Name: CBC II KIT WITH 3/16" ROUND PVC WOUND DRAIN
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• MDR Report Key: 6245065
• Report Number: 0001811755-2017-00044
• Device Sequence Number: 1477922
• Product Code: CAC
• UDI-Device Identifier: 07613327051278
• UDI-Public: 07613327051278
• Combination Product (Y/N): N
• PMA/510(K) Number: K970714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2017

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: 0225426000
• Device Lot Number: 16051012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1