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	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer discarded.
Event or Problem Description
The user facility reported that the device stopped working after blood was collected from the patient during a procedure.It is unknown how much blood was collected but the patient did not require any additional blood.There was no delay, no medical intervention, and no adverse consequences.

• 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: 8135673
• Report Number: 0001811755-2018-02685
• Device Sequence Number: 16709663
• Product Code: CAC
• UDI-Device Identifier: 34546540867699
• UDI-Public: 34546540867699
• 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
• Report Date (Section B): 12/05/2018

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: 17219012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1