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

Model Number	RTU16M
Medical Device Problem Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/14/2022
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.
Event or Problem Description
It was reported that the patient had bleeding when they tried to insert the intermittent catheters.It was noted that the patient was new to catheterizing.Per follow-up via phone on 03feb2022, it was reported that the patient using the catheters went well but then they started stopping up with blood and clots.Patient went to the emergency room and they did a procedure to clean out the urethra and placed a foley catheter.
Event or Problem Description
It was reported that the patient had bleeding when they tried to insert the intermittent catheters.It was noted that the patient was new to catheterizing.Per follow-up via phone on (b)(6) 2022, it was reported that the patient using the catheters went well but then they started stopping up with blood and clots.Patient went to the emergency room and they did a procedure to clean out the urethra and placed a foley catheter.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential failure mode could be "biocompatibility issues(bleeding)".Therefore, a potential root cause for this failure could be "unsuitable material".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warnings: to help reduce the potential risk of infection and/or other complications, do not re-use.If discomfort or any sign of trauma occurs, discontinue use immediately and consult your doctor"."precautions: please consult your doctor before using this product if any of the following conditions are present: fever, chills, back pain, discomfort on emptying the bladder, 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)." the information provided by bard represents all of 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 bard.

• 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: 13621155
• Report Number: 1018233-2022-00923
• Device Sequence Number: 5817331
• Product Code: GBM
• UDI-Device Identifier: 06948796203974
• UDI-Public: (01)06948796203974
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/29/2022
• Report Date (Section F): 01/21/2022

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 Model Number: RTU16M
• 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: 01/14/2022
• Event Location: Other
• Date Report to Manufacturer: 01/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Male