MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC WOUND DRAIN; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225414000

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/12/2014

Event Type  Injury  

Event Description

It was reported that during a total knee arthroplasty, the cbc ii drain broke off inside of the surgical wound.The procedure was completed successfully with no delay.It was reported that a second surgery was required two days later to remove the drain fragment from below the fascia.The patient remained hospitalized an additional day following the revision surgery and was discharged with no further medical intervention required.

Manufacturer Narrative

The device will not be returned as it was discarded by the user facility; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.

• Brand Name: CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC WOUND DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3943437
• MDR Text Key: 4643224
• Report Number: 0001811755-2014-02567
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2014

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: 0225414000
• Device Lot Number: 14079012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2014
• 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