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

Model Number	RTU16M
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the whole week patient had an infection and wanted to be back to the original catheters.It was stated that patient was having trouble with coude tip and wanted straight tip catheters.It was unknown what medical intervention was reported.
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 whole week patient had an infection and wanted to be back to the original catheters.It was stated that patient was having trouble with coude tip and wanted straight tip catheters.It was unknown what medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode for this is event would be "biocompatibility issues " and a potential root cause for this failure could be," unsuitable material".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." 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.The device was not returned.
Event or Problem Description
It was reported that the whole week patient had an infection and wanted to be back to the original catheters.It was stated that patient was having trouble with coude tip and wanted straight tip catheters.It was unknown what medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode could be "biocompatibility issues".Therefore, a potential root cause for this failure could be "unsuitable material".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: "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"."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)." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• 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: 14017145
• Report Number: 1018233-2022-01927
• Device Sequence Number: 17382842
• Product Code: GBM
• UDI-Device Identifier: 06948796203974
• UDI-Public: (01)06948796203974
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 07/04/2022
• Report Date (Section F): 03/14/2022

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: 03/09/2022
• Event Location: Other
• Date Report to Manufacturer: 03/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/13/2022; 07/01/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 06/03/2022; 07/21/2022
• 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