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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product discarded.
Event or Problem 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
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• MDR Report Key: 7857124
• Report Number: 0001811755-2018-01638
• Device Sequence Number: 19223805
• Product Code: CAC
• UDI-Device Identifier: 34546540867606
• UDI-Public: 34546540867606
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K970714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0225414000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other