MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC WOUND DRAIN; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225426000

Device Problem Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2015

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility a loss of suction occurred, causing a leak at the wound site.No medical intervention, no adverse consequences and no delay were reported with this event.

Event Description

It was reported that during a surgical procedure at the user facility a loss of suction occurred, causing a leak at the wound site.No medical intervention, no adverse consequences and no delay were reported with this event.

Manufacturer Narrative

Evaluation in progress.

Manufacturer Narrative

The unit was not available to stryker puerto rico (spr) for evaluation.Therefore, the reported condition cannot be confirmed.

• Brand Name: CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND 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: 4637655
• MDR Text Key: 5753197
• Report Number: 0001811755-2015-01139
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K952224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/27/2015

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: 14276012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 03/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2014
• 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