MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD URINARY INTERMITTENT DRAINAGE CATHETER; SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER

Catalog Number	274100 / 27410
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	Sepsis (2067); Tissue Breakdown (2681)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
According to the available information, the complaint described in (b)(4) concerns a patient with bladder cancer who experienced a traumatic catheterisation with sc standard male.Following use of the speedicath catheter to empty the bladder, the speedicath catheter was used for bcg instillation (as a treatment for the bladder cancer), which caused bcg sepsis and hospitalization of the patient.The risk of harm is short-term, and the patient is no longer hospitalized.

• Brand Name: SPEEDICATH STANDARD URINARY INTERMITTENT DRAINAGE CATHETER
• Common Device Name: SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usgab giovanna abugre ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18827347
• Report Number: 3006606901-2024-00003
• Device Sequence Number: 12732444
• Product Code: GBM
• UDI-Device Identifier: 05708932020275
• UDI-Public: 05708932020275
• Combination Product (Y/N): N
• PMA/510(K) Number: K023254
• 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): 03/04/2024

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: Lay User/Patient
• Device Expiration Date: 03/25/2025
• Device Catalogue Number: 274100 / 27410
• Device Lot Number: 9102139_2741001404
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown