MAUDE Adverse Event Report: STRYKER STRYKRER CBC11 CONSTAVAC BLOOD CONERATION SYSTEM WITH QUICK DISCONNECT AND OL. 1

Model Number 0225-028-926

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Patient was at hospital for right knee surgery on (b)(6) 2017.When patient went for his follow-up visit to his surgeon, the x-ray showed that the tip of the knee drain was in his knee, 6 eyelets out.

• Brand Name: STRYKRER CBC11 CONSTAVAC BLOOD CONERATION SYSTEM WITH QUICK DISCONNECT AND OL. 1
• Type of Device: STRYKRER CBC11 CONSTAVAC BLOOD CONERATION SYSTEM WITH QUICK DISCONNECT AND OL. 1
• Manufacturer (Section D): STRYKER; kalamazoo MI 49001
• MDR Report Key: 7208998
• MDR Text Key: 97967849
• Report Number: MW5074678
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0225-028-926
• Device Lot Number: 17230012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 108