MAUDE Adverse Event Report: ASP JOHNSON & JOHNSON CYCLESURE 24; STERRAD

Device Problem Sterility (1595)

Patient Problem No Code Available (3191)

Event Date 01/17/2014

Event Type  malfunction  

Event Description

Received notification from the company that the biological for the sterrad machines will have limited or no availability for at least 5 months.The biologic is grown, and therefore cannot be expedited.Apparently, one of their facilities had an issue and all the product at that facility had to be discarded.There is only one other facility in the united states that produces this specific biologic that is validated for the sterrad machines.The representative stated to us that there is no other biologic available in the market.Product # 46464 is listed.Suspect medical device 4.

• Brand Name: CYCLESURE 24
• Type of Device: STERRAD
• Manufacturer (Section D): ASP JOHNSON & JOHNSON; 33 technology drive; irvine CA 92618
• MDR Report Key: 3606742
• MDR Text Key: 4161137
• Report Number: 3606742
• Device Sequence Number: 1
• Product Code: FRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Other Device ID Number: 46464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2014
• Distributor Facility Aware Date: 01/17/2014
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other