MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CBCII W/QUICK DISCONNECT, 1/8 INCH ROUND PVC DRAIN & TROCAR"; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225028914

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

Custoner states product is not available to send back.

Event Description

It was reported at the end of a total knee replacement a drain was placed in the surgical wound of the patient.When the drain was removed, a portion of the drain remained in the patient.A revision surgery was completed to remove the fragment of tubing.The revision surgery was completed successfully with no delay, no medical intervention, and no adverse consequences reported.

• Brand Name: CBCII W/QUICK DISCONNECT, 1/8 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6085999
• MDR Text Key: 59393478
• Report Number: 0001811755-2016-02697
• Device Sequence Number: 1
• Product Code: CAC
• 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
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0225028914
• Device Lot Number: 16145012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2016
• 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): Other