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 Codes	Hypersensitivity/Allergic reaction (1907); Anaphylactoid / Anaphylaxis (2218)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Dealer reported that between 2023 and 2025 after a cystoscopy procedure a patients experienced 5 episode of allergy and anaphylaxis of which two of them resulted in a trip to the er.
Additional Manufacturer Narrative
Similar complaint has been recorded for 73-opa28 within the past year.Unable to review dhr and testing information without lot code information.Unknown information about the affected patients, whether they had or had previously had bladder cancer.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 was provided by the customer.Device not returned.

• 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, henrieta rd.; rush NY 14543
• Manufacturer Contact: stephanie wasielewski ; 6789 w, henrieta rd.; rush, NY 14543 ; 8472574500
• MDR Report Key: 25176804
• Report Number: 1319130-2026-00003
• Device Sequence Number: 10624003
• 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): 05/14/2026

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
• Device Model Number: 73-OPA28
• Device Catalogue Number: 73-OPA28
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown