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 Therapeutic Effects, Unexpected (2099)

Event Date 04/10/2015

Event Type  Injury  

Event Description

It was reported that during an x-ray after a surgical procedure at the user facility, it was noticed that a piece of the drain tube fractured off and was left inside of the patient.A revision surgery was completed to remove the fragment of tubing.

Event Description

It was reported that during an x-ray after a surgical procedure at the user facility, it was noticed that a piece of the drain tube fractured off and was left inside of the patient.A revision surgery was completed to remove the fragment of tubing.

Manufacturer Narrative

The claimed broken wound drain tube condition was confirmed.The device was scrapped by stryker.

Manufacturer Narrative

Failure analysis is in progress.

• 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 MI 49001 006
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4746708
• MDR Text Key: 5825525
• Report Number: 0001811755-2015-01608
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• 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: 14298012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention