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

Catalog Number	RTU16M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/23/2024
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 stopped using intermittent catheters briefly because of an infection and a surgery unrelated to urological issues.They did not specify if catheters or any other urological issues were related to infection.It was unknown what medical intervention was provided.
Event or Problem Description
It was reported that the patient stopped using intermittent catheters briefly because of an infection and a surgery unrelated to urological issues.They did not specify if catheters or any other urological issues were related to infection.It was unknown what medical intervention was provided.Per additional information received via phone on 05dec2024, stated that the customer did not experience infection from the catheters.The customer had an unrelated obstruction which caused the infection and need for surgery.The customer was still using the catheters.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.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.

• Brand Name: 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: 20723963
• Report Number: 1018233-2024-07190
• Device Sequence Number: 3714882
• Product Code: GBM
• UDI-Device Identifier: 06948796203974
• UDI-Public: (01)06948796203974
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K192468
• 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): 11/27/2024
• Report Date (Section F): 11/12/2024

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 Catalogue Number: RTU16M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2024
• Event Location: Other
• Date Report to Manufacturer: 11/12/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/12/2024
• 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: Male