MAUDE Adverse Event Report: BAUSCH + LOMB 25GA POSTERIOR PRODCEDURAL PACK WITH INTEGRATED VENTED AFI&FF; UNIT, PHACOFRAGMENTATION

Model Number	BL5425V
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Valvular Stenosis (2697)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation completed.One 25ga vitrectomy cutter was returned loose in a plastic bag along with a bl5425v pack from lot w0330.The expiration date on the label is 2019-03-16.The tip protector was not returned.The needle was bent.The port window was in the opened position.There was dried solution visible in the tubing.The back cap was aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no defects were found.A functional test was performed using a stellaris pc system.The cutter had good clean cuts at the various cut rates and had good aspiration.The cause of the bent needle cannot be determined.The sterilization and lot history records were reviewed and found to be acceptable.
Event or Problem Description
The doctor reported the cutter was not cutting efficiently.Additional information: they opened a new cutter to complete the surgery.There was no harm to the patient.

• Brand Name: 25GA POSTERIOR PRODCEDURAL PACK WITH INTEGRATED VENTED AFI&FF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7393481
• Report Number: 0001920664-2018-00041
• Device Sequence Number: 16410963
• Product Code: HQC
• UDI-Device Identifier: 00757770058600
• UDI-Public: (01)00757770058600(17)190316
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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
• Operator of Device: Physician
• Device Expiration Date: 03/16/2019
• Device Model Number: BL5425V
• Device Catalogue Number: BL5425V
• Device Lot Number: W0330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1