MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO CBC II-(1/8" KIT) PKG/6 WORLD; APPARATUS, AUTOTRANSFUSION

Catalog Number 0225414000W

Device Problem Detachment Of Device Component (1104)

Patient Problem Blood Loss (2597)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Device has not yet been received for evaluation.

Event Description

It was reported that after a surgical procedure at the user facility, the patient pulled out the tube connector resulting in blood leaking onto the bed.The patient required a new drain line to be placed.Additional information has been requested from the user facility.

Manufacturer Narrative

Device not returned for evaluation.

Event Description

It was reported that after a surgical procedure at the user facility, the patient pulled out the tube connector resulting in blood leaking onto the bed.The patient required a new drain line to be placed.

• Brand Name: CBC II-(1/8" KIT) PKG/6 WORLD
• 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5131997
• MDR Text Key: 27784016
• Report Number: 0001811755-2015-03670
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/09/2015

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: 0225414000W
• Device Lot Number: 14351012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2014
• 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