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

Catalog Number BUC14F

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

Patient Problem Urinary Tract Infection (2120)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient had 1 urinary tract infection from using the intermittent catheter in the last 12 months or since liberator last spoke with the patient.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention was unknown.

Event Description

It was reported that the patient had 1 urinary tract infection from using the intermittent catheter in the last 12 months or since liberator last spoke with the patient.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention was unknown.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode identified is "biocompatibility issues" and a potential root cause for this failure mode could be "unsuitable material".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.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: "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.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.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).The catheter is for single use only and must then be discarded.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.If desired, apply water-soluble lubricant to catheter.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.H3 other text : the device was not returned.

• Brand Name: 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: 15251593
• MDR Text Key: 298157497
• Report Number: 1018233-2022-06544
• 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,Followup
• Report Date: 08/15/2022,09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: BUC14F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2022
• Event Location: Other
• Date Report to Manufacturer: 08/15/2022
• Date Manufacturer Received: 09/14/2022
• 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