MAUDE Adverse Event Report: BAUSCH + LOMB 25GA COMB PK W V&AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5525WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested for evaluation however it has not yet been received.Manufacturing and sterilization records were reviewed and found to be acceptable.
Event or Problem Description
The vitrectomy cutter was aspirating yet not cutting at the start of the surgery.There was no patient injury.
Additional Manufacturer Narrative
One bl5525wv pack from lot w0343 was received.The collection cassette and tubing were clean and dry.The cutter with tubing was lying loose in the pack.The tip protector was in place, as it should be.The needle was not bent.The port window was in the opened position.There was fluid both in the yellow striped line and the blue striped line.The back cap was aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.Functional testing was performed using a stellaris pc.Air was exiting the port window.Upon closer inspection it was discovered that the yellow striped tubing (aspiration line) and the blue striped tubing (air line) were reversed on the back cap barbs.The blue striped tubing (air line) was attached to the aspiration port on the back cap.The yellow striped tubing (aspiration line) was attached to the air port barb on the back cap.This cutter cannot function properly in this condition.Due to evidence of fluid in both the yellow and the blue striped tubing, it cannot be determined when the tubing came to be reversed.The tubing lines may have been reversed when they were attached in manufacturing or they may h ave been reversed by the customer in an attempt to mitigate the problem.A 100% inspection using an automated test fixture is performed on the line by manufacturing personnel after assembly.The operators involved in the manufacturing and testing of this device have been retrained for awareness purposes.We will continue to monitor trends for this product to determine if further action is required.

• Brand Name: 25GA COMB PK W V&AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7487399
• Report Number: 0001920664-2018-00053
• Device Sequence Number: 2052811
• Product Code: HQC
• UDI-Device Identifier: 00757770058631
• UDI-Public: (01)00757770058631(17)190316
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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: Health Professional
• Device Expiration Date: 03/16/2019
• Device Model Number: BL5525WV
• Device Catalogue Number: BL5525WV
• Device Lot Number: W0343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1