MAUDE Adverse Event Report: BAUSCH + LOMB SYNERGETICS ENTRY SITE ALIGNMENT SYSTEM W/VALVE; 27GA VALVED ESA SYSTEM

Model Number	BL5240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.Report 1 of 7 see: 1932402-2018-00005, 00006, 00007, 00008, 00009, 00010.
Event or Problem Description
It was reported the patient developed endophthalmitis after a procedure in which bausch + lomb devices were used.The cause of the endophthalmitis has not been determined.Additional information regarding possible treatment and patient outcome has been requested.

• Brand Name: SYNERGETICS ENTRY SITE ALIGNMENT SYSTEM W/VALVE
• Common Device Name: 27GA VALVED ESA SYSTEM
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7650686
• Report Number: 0001932402-2018-00004
• Device Sequence Number: 1651832
• Product Code: NGY
• UDI-Device Identifier: 20841305111374
• UDI-Public: (01)20841305111374(17)190508
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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
• Operator of Device: Physician Assistant
• Device Expiration Date: 05/08/2019
• Device Model Number: BL5240
• Device Lot Number: M0013382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention