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	Inadequate Filtration Process (2308)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discarded by the customer.
Event or Problem Description
The user facility reported that an improper blood infusion filter was used with the device found after a transfusion procedure.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: 8148996
• Report Number: 0001811755-2018-02726
• Device Sequence Number: 11114316
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/10/2018

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1