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

Model Number	RTU16C
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	04/01/2022
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.The device was not returned.
Event or Problem Description
It was reported that the bever coude hydrophilic intermittent catheters that the patient received were very difficult to get past the patient's prostate and difficult to control.The patient could not grab the tube, so they could not navigate the catheter at all.It was stated that the patient spent the night in the emergency room with a urinary tract infection.It was unknown what medical intervention was provided for urinary tract infection.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential failure mode for this failure could be "catheter too long / outer diameter too large".Therefore, a potential root cause for this failure could be "incorrect extruding parameters".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.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: 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".The ifu also states "do not use the catheter if there is no water inside the inner packaging or if the product is past its expiry date".The ifu also states: "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".Correction: f 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 bever coude hydrophilic intermittent catheters that the patient received were very difficult to get past the patient's prostate and difficult to control.The patient could not grab the tube, so they could not navigate the catheter at all.It was stated that the patient spent the night in the emergency room with a urinary tract infection.It was unknown what medical intervention was provided for urinary tract infection.

• 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: 14220676
• Report Number: 1018233-2022-03068
• Device Sequence Number: 14799787
• Product Code: GBM
• UDI-Device Identifier: 06948796204001
• UDI-Public: (01)06948796204001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: RTU16C
• Device Catalogue Number: RTU16C
• Device Lot Number: T11416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2022
• 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: 04/27/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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