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

Model Number	BUC14M
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/28/2022
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 had an infection from intermittent catheter and had to go to the emergency room.It was unknown what medical intervention was provided for infection.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential failure mode could be "biocompatibility issues".A potential root cause for this failure could be ¿unsuitable material¿.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.Dispose of appropriately after procedure.If discomfort or any sign of trauma occurs, discontinue use immediately and consult your doctor.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: 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.
Event or Problem Description
It was reported that the patient had an infection from the intermittent catheter and had to go to the emergency room.It was unknown what medical intervention was provided for infection.
Event or Problem Description
It was reported that the patient had an infection from the intermittent catheter and had to go to the emergency room.It was unknown what medical intervention was provided for infection.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode could be "biocompatibility issues".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.Dispose of appropriately after procedure.If discomfort or any sign of trauma occurs, discontinue use immediately and consult your doctor"."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: 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 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 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: 13872640
• Report Number: 1018233-2022-01524
• Device Sequence Number: 4715952
• Product Code: GBM
• UDI-Device Identifier: 06948796203844
• UDI-Public: (01)06948796203844
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111405
• 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): 06/14/2022
• Report Date (Section F): 03/07/2022

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: BUC14M
• Device Catalogue Number: BUC14M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2022
• Event Location: Other
• Date Report to Manufacturer: 03/07/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/04/2022; 06/14/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/23/2022; 07/05/2022
• 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