MAUDE Adverse Event Report: HANGZHOU BEVER MEDICAL DEVICES CO., LTD. BD INTERMITTENT CATHETER

Catalog Number	BUC14M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the patient had a urinary tract infection and had to use more product.It is unclear if the lot number was requested.No additional information provided.It was unknown what medical intervention was reported for infection.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A dhr review is not required as the lot number is unknown.The instructions for use were found adequate and states the following: "contraindications: the product is forbidden for use if the patient has acute urethritis, acute prostatitis, acute epididymitis, and/or acute urinary tract bleeding or injury".Warnings: to help reduce the potential risk of infection and/or other complications, do not re-use.Dispose of appropriately after procedure.If discomfort or any sign of trauma occurs, discontinue use immediately and consult your doctor.Prior to use of this device, be sure to read the complete information on how to use this device including warnings, precautions and instructions for use, and all other package inserts and labels supplied with the product and accessories.Please consult your doctor before using this product if any of the following conditions are present: severed urethra, unexplained urethral bleeding, pronounced stricture, false passage, urethritis - inflammation of the urethra, prostatitis - inflammation of the prostate gland, epididymitis - inflammation of the epididymis (testicle tube)." udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the patient had a urinary tract infection and had to use more product.It is unclear if the lot number was requested.No additional information provided.It was unknown what medical intervention was reported for infection.Per wife via phone on (b)(6) 2025, it was reported, they did not make complaint and that nothing is wrong with the catheter but that he gets uti's all the time.

• Brand Name: BD INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): HANGZHOU BEVER MEDICAL DEVICES CO., LTD.; no. 8-1, longquan road; cangqian town, yuhang district; hangzhou, zhejiang 31112 1; CH 311121
• MDR Report Key: 21832596
• Report Number: 1018233-2025-02600
• Device Sequence Number: 17189771
• Product Code: GBM
• UDI-Device Identifier: 06948796203844
• UDI-Public: (01)06948796203844
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: Lay User/Patient
• Device Catalogue Number: BUC14M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/24/2025
• Event Location: Other
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown