MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CBCII BLOOD CONSERVATION RESERVOIR ONLY; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225028000

Device Problem Biocompatibility (2886)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2017

Event Type  malfunction  

Event Description

The user facility reported that they discovered something white spilled on the blue towel inside the package during opening the product.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

The reported event was not confirmed during the device evaluation.

Event Description

The user facility reported that they discovered something white spilled on the blue towel inside the package during opening the product.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: CBCII BLOOD CONSERVATION RESERVOIR ONLY
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6714339
• MDR Text Key: 80058643
• Report Number: 0001811755-2017-01382
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 4546540185273
• UDI-Public: (01)4546540185273
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0225028000
• Device Lot Number: 17032012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1