MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. MCKESSON; MCKESSON OPA/28 HLD

Model Number	73-OPA28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaints have been recorded for 73-opa28, lots 607423, 630099, 638686, 628856.The label states "mckesson opa/28 should not be used to reprocess any urological instrumentation to be utilized for cystoscopy or other urological procedures for patients with a history of bladder cancer.In rare instances similar ortho-phthaladehyde (opa) based disinfectants have been associated with anaphylaxis-like reactions in bladder cancer patients undergoing repeated cystoscopies." no additional information provided by customer.Device not returned.
Event or Problem Description
Dealer/distributor reported allergic reactions occuring in 3 patients on separate occasion's.

• Brand Name: MCKESSON
• Common Device Name: MCKESSON OPA/28 HLD
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 6789 w. henrietta rd.; rush NY 14543
• Manufacturer (Section G): CROSSTEX INTERNATIONAL INC.; 6789 w. henrietta rd.; rush NY 14543
• Manufacturer Contact: stephanie wasielewski ; 6789 w. henrietta rd.; rush, NY 14543 ; 8472574500
• MDR Report Key: 21900722
• Report Number: 1319130-2025-00003
• Device Sequence Number: 11783329
• Product Code: MED
• UDI-Device Identifier: 10612479185989
• UDI-Public: (01)10612479185989
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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: Health Professional
• Device Model Number: 73-OPA28
• Device Lot Number: 607423, 630099, 638686, 628856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown