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 Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/03/2015

Event Type  Injury  

Manufacturer Narrative

The product was not available for return.

Event Description

It was reported that during a drain removal from a patient's knee at the user facility that the end of the tubing fractured and small fragment was left in the patient's knee.An arthroscopic procedure was completed to remove the device fragment from the patient.After the removal of the fragment, the patient had 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5193602
• MDR Text Key: 30009799
• Report Number: 0001811755-2015-03961
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0225028916
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention