MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS BAERVELDT SHUNT; SURGICAL ADJUNCTS

Model Number	BG101-350
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that when the doctor tried to flush the silicone tube, it would not advance.The event occurred during handling/prior to insertion.There was no patient contact.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Product was returned and device evaluation was performed accordingly: device available for evaluation? yes.Returned to manufacturer on: 04/17/2018.Device returned to manufacturer? yes.Device evaluation: the returned product was in the original package.The sample was inspected twice by two qualified final inspection operators using 12x magnification.There are traces of a dried yellow substance in the tube and there is also a plug in the tube.Investigation of the return sample and the condition of the return sample do not suggest the obstruction was introduced during manufacturing.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product was not returned for investigation.The reported complaint was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: BAERVELDT SHUNT
• Common Device Name: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6805842
• Report Number: 9614546-2017-00769
• Device Sequence Number: 1852737
• Product Code: KYF
• UDI-Device Identifier: 05050474513013
• UDI-Public: (01)05050474513013(17)190531
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 09/04/2018
• 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: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: BG101-350
• Device Catalogue Number: 23030819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 01/15/2018; 08/10/2018
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 02/08/2018; 09/04/2018
• 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