MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CBC II KIT WITH 3/16" ROUND PVC WOUND DRAIN; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225426000

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2016

Event Type  malfunction  

Event Description

The user facility reported that the device's vacuum stopped working during a procedure.Approximately 100ml of blood was collected.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.

Manufacturer Narrative

The reported event was duplicated.

Event Description

The user facility reported that the device's vacuum stopped working during a procedure.Approximately 100ml of blood was collected.The procedure was completed successfully with no delay, no medical intervention, and no adverse consequences reported.

• Brand Name: CBC II KIT WITH 3/16" 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6245065
• MDR Text Key: 64586179
• Report Number: 0001811755-2017-00044
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 07613327051278
• UDI-Public: 07613327051278
• Combination Product (y/n): N
• 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,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0225426000
• Device Lot Number: 16051012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2016
• 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