MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO 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 07/22/2018

Event Type  Injury  

Manufacturer Narrative

Product discarded.

Event Description

The user facility reported that the part of the drain was left inside the patient after a procedure.A revision surgery was completed without any further complications or medical intervention needed for the patient.

• Brand Name: CBCII BLOOD CONSERVATION KIT W/1/8 INCH ROUND PVC WOUND DRAIN
• 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7857124
• MDR Text Key: 119638923
• Report Number: 0001811755-2018-01638
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 34546540867606
• UDI-Public: 34546540867606
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K970714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• 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