MAUDE Adverse Event Report: CLINICAL RESEARCH CONSULTANTS, INC. SELF-THREADING MONOKA; PLUG, PUNCTUM

Model Number S1-1800U

Device Problems Device Expiration Issue (1216); Delivered as Unsterile Product (1421)

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

Event Date 08/08/2017

Event Type  malfunction  

Event Description

It was reportedly noted prior to operative procedure that the sterilization indicator dots located on unopened monoka ritleng stent packaging indicated that the stents were not sterile.The date located on the package indicated that it was still sterile.Two packages with different lot numbers were noted to be expired by the color of the dot.These packages were removed from stock and given to the or materials management for follow up.No reported patient harm.

• Brand Name: SELF-THREADING MONOKA
• Type of Device: PLUG, PUNCTUM
• Manufacturer (Section D): CLINICAL RESEARCH CONSULTANTS, INC.; barbara fant; 3308 jefferson ave upper level; cincinnatti OH 45220
• MDR Report Key: 6961449
• MDR Text Key: 89732083
• Report Number: 6961449
• Device Sequence Number: 1
• Product Code: LZU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: S1-1800U
• Device Lot Number: 1554385
• Other Device ID Number: 1554871
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2017
• Type of Device Usage: N
• Patient Sequence Number: 1