MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; THE SURGERY CENTER CATARACT

Model Number	VAL002CATSD
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that following a cataract surgery where the procedure pack was used, the patient experienced an unspecified infection.Reportedly, the patient was referred to a retinal specialist where unspecified cultures were drawn and an unspecified antibiotic treatment was started.The patient has required follow-up care from the retinal specialist.No additional information was provided by the reporting facility and it is unknown what component(s) from the procedure pack were used at the time of the cataract surgery.No sample was returned to the pack manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported infection and the need for medical intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a patient experienced an unspecified infection.
Additional Manufacturer Narrative
Lot number corrected in section d4 following receipt of additional information from the reporting facility.The pack manufacturer received samples for evaluation from the reporting facility.When the samples were examined, no holes, tears, or punctures that could comporomise sterility were noted on the breather pouch.When the samples were opened and examined for particulate, missing components, or other possible production assembly issues, none were noted.A root cause for the reported incident was unable to be determined.If additional relevant information becomes available, another supplemental mdr will be filed.
Additional Manufacturer Narrative
Additional information was received by the pack manufacturer.Reportedly, the patient was diagnosed with endopthalmitis for which an unspecified antibiotic therapy was received.The patient reportedly began to experience symptoms of the infection on (b)(6) 2020.The cataract surgery was performed on (b)(6) 2020.The patient remains under the care of the retinal specialist at this time.If additional relevant information becomes available another supplemental medwatch will be filed.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: THE SURGERY CENTER CATARACT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10963375
• Report Number: 1423395-2020-00042
• Device Sequence Number: 982821
• Product Code: OJK
• UDI-Device Identifier: 10193489259063
• UDI-Public: 10193489259063
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2021

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?: No
• Operator of Device: Other
• Device Model Number: VAL002CATSD
• Device Catalogue Number: VAL002CATSD
• Device Lot Number: 20BBW231
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020; 01/13/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 01/07/2021; 01/14/2021
• 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