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

Model Number	BG102-350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Endophthalmitis (1835); Vitrectomy (2643); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown/not provided.If implanted; give date: exact date not provided only known as during the summer 2017.(b)(6).(b)(4).Device evaluation: product testing could not be performed because the product was not returned.The complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed no similar complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a glaucoma shunt (bg102-350) implanted in the summer of 2017 was exposed from the sclera and it caused endophthalmitis.The glaucoma shunt was put on a 6 mm × 6 mm sclera semi-section incision, but it pierced and exposed the sclera.The product was explanted and vitrectomy was performed at the same time.Antimicrobial treatment is currently being performed.The preoperative vision was 0.06, but it dropped to 0.02 last fall and now the symptoms are stable with a manual valve.No additional information was 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: 8507602
• Report Number: 9614546-2019-00331
• Device Sequence Number: 1650578
• Product Code: KYF
• UDI-Device Identifier: 05050474513006
• UDI-Public: (01)05050474513006(17)190124
• Combination Product (Y/N): Y
• PMA/510(K) Number: K955455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2019
• Device Model Number: BG102-350
• Device Catalogue Number: 23030818
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 11/11/2020
• 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
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005