MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MINI GPS 6 PACK; BLOOD BANK SUPPLIES

Model Number N/A

Device Problems Break (1069); Contamination (1120); Improper Flow or Infusion (2954)

Patient Problem No Code Available (3191)

Event Date 08/21/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a procedure utilizing a platelet separation kit for the extraction of platelet rich plasma (prp) on (b)(6) 2014.During the procedure, the kit did not separate the prp properly and became contaminated with what looked like red blood cells (rbcs).The kit appeared to have a break in the seal between the chambers.A different kit was used to complete the procedure; however, a delay of at least 30 minutes occurred while the other kit was set up.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of the inspection records and certificate of conformance, indicates that lot was received with no recorded anomaly or deviation.

• Brand Name: MINI GPS 6 PACK
• Type of Device: BLOOD BANK SUPPLIES
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4133900
• MDR Text Key: 4921035
• Report Number: 0001825034-2014-07902
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PBK070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2014

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?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 800-1007A
• Device Lot Number: 400389
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention