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

Catalog Number RTU14F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 08/16/2022

Event Type  Injury  

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential failure mode for this event would be "biocompatibility issues (uti) " and a potential root cause for this failure could be," unsuitable material".It was 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.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.".

Event Description

It was reported that the patient had not used all of last order of the intermittent catheter because patient got a really bad urinary tract infection.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention was unknown.

• Brand Name: BD INTERMITTENT CATHETER
• Type of Device: 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: 15347059
• MDR Text Key: 299148933
• Report Number: 1018233-2022-06836
• Device Sequence Number: 1
• Product Code: GBM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2022,08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTU14F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/16/2022
• Event Location: Other
• Date Report to Manufacturer: 08/25/2022
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female