MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. BAERVELDT SHUNT; SURGICAL ADJUNCTS

Model Number	BG103-250
Medical Device Problem Codes	Product Quality Problem (1506); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.Device evaluation: the product was returned to the manufacturing site for evaluation.The product was inspected by a qualified inspector using a microscope with a 12x magnification.It can be seen that the tube is blocked from the inside out.Further investigation has been opened to address the issue, corrective actions will be implanted if required based on the outcome of the investigation.Manufacturing record review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.The search revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that glaucoma shunt did not prime.The product was returned for investigation and found to be obstructed.No further information provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: BAERVELDT SHUNT
• Common Device Name: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8364412
• Report Number: 9614546-2019-00155
• Device Sequence Number: 1341157
• Product Code: KYF
• UDI-Device Identifier: 05050474513013
• UDI-Public: (01)05050474513013(17)190629
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K955455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• Report Date (Section F): 01/01/2005

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: 06/29/2019
• Device Model Number: BG103-250
• Device Catalogue Number: BG103250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005