MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CBCII W/QUICK DISCONNECT, 1/4 INCH ROUND PVC DRAIN & TROCAR"; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225028916

Device Problem Biocompatibility (2886)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Event Description

The user facility reported that there was a couple of spots on the outside of the plastic tray during unpacking the box.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

The device was not available for the evaluation.

Event Description

The user facility reported that there was a couple of spots on the outside of the plastic tray during unpacking the box.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: CBCII W/QUICK DISCONNECT, 1/4 INCH ROUND PVC DRAIN & TROCAR"
• 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7140144
• MDR Text Key: 95644491
• Report Number: 0001811755-2017-02486
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 4546540867520
• UDI-Public: (01)4546540867520
• 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: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0225028916
• Device Lot Number: 17115012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2017
• 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