MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CBCII 1/8"DBL. TROCAR W/Q.DISC; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225028085S1

Device Problem Break (1069)

Patient Problems Abscess (1690); Device Embedded In Tissue or Plaque (3165)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

Product is not available.

Event Description

The user facility reported that 6 months after surgery, the patient had an abscess on their knee.The patient needed revision surgery to remove drain pieces from their knee.There were no further complications and no additional medical intervention was needed.

• Brand Name: CBCII 1/8"DBL. TROCAR W/Q.DISC
• 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: 6352931
• MDR Text Key: 68135928
• Report Number: 0001811755-2017-00666
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/23/2017

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: 0225028085S1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 02/23/2017
• 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): Other