MAUDE Adverse Event Report: HANGZHOU BEVER MEDICAL DEVICES CO., LTD. BEVER MALE COUDÉ POLYURETHANETHERMOPLASTIC HYDROPHILIC CATH 12 FR 16¿ LENGTH; INTERMITTENT CATHETER

Model Number	RTU16C
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Discomfort (2330)
Date of Event	03/31/2022
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 intermittent catheters were uncomfortable.Per additional information received via liberator on (b)(6) 2022, it was stated that the intermittent catheters were weak and the patient was experiencing urinary tract infection.Patient never had issues with primary item magic 3 go intermittent catheter.It is unknown what medical intervention was provided.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode is "catheter strength issue (too soft)" and potential root cause for this failure could be due to "raw material is too soft".It was unknown whether the device had met 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: 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.If discomfort or any sign of trauma occurs, discontinue use immediately and consult your doctor."inspect the catheter before use.If the inner packaging is open or broken, do not use the catheter and do not try to re-sterilize it.Self-catheterization should only be carried out under medical advice and only in accordance with instructions provided.You should always follow the plan of care and advice given by your healthcare professional.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: 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 catheter is for single use only and must then be discarded.Instructions for intermittent catheters: 1.Wash your hands thoroughly with soap and water.2.Remove catheter from the pack.3.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.4.Gently insert rounded end of catheter into urethra until urine begins to flow.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands.H11: section a through f - 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.
Event or Problem Description
It was reported that the intermittent catheters were uncomfortable.Per additional information received via liberator on 05apr2022, it was stated that the intermittent catheters were weak and the patient was experiencing urinary tract infection.Patient never had issues with primary item magic 3 go intermittent catheter.It is unknown what medical intervention was provided.

• Brand Name: BEVER MALE COUDÉ POLYURETHANETHERMOPLASTIC HYDROPHILIC CATH 12 FR 16¿ LENGTH
• 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: 14274814
• Report Number: 1018233-2022-03172
• Device Sequence Number: 5908196
• Product Code: GBM
• UDI-Device Identifier: 06948796204001
• UDI-Public: (01)06948796204001
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/30/2022
• Report Date (Section F): 04/11/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTU16C
• Device Catalogue Number: RTU16C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/31/2022
• Event Location: Other
• Date Report to Manufacturer: 04/11/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 07/19/2022
• 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: Other
• Patient Sex: Male