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

Model Number	RTU16C
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/27/2022
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 patient was unable to insert 16fr bever coude hydrophilic catheters anymore and had been getting urinary tract infections while attempting to use the 16fr catheters.It was unknown what medical intervention was provided for urinary tract infections.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be "catheter outer diameter too large".Therefore, a potential root cause for this failure could be "incorrect extruding parameters".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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." 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.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations." 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 patient was unable to insert 16fr bever coude hydrophilic catheters anymore and had been getting urinary tract infections while attempting to use the 16fr catheters.It was unknown what medical intervention was provided for urinary tract infections.

• Brand Name: BD READY TO USE 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: 15028797
• Report Number: 1018233-2022-05504
• Device Sequence Number: 6147829
• Product Code: GBM
• UDI-Device Identifier: 06948796204001
• UDI-Public: (01)06948796204001
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/21/2022
• Report Date (Section F): 07/06/2022

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: 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: 06/27/2022
• Event Location: Other
• Date Report to Manufacturer: 07/06/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/05/2022
• 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