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

Catalog Number	BUC14M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that customer was treated for urinary tract infection.Customer informed this due to something that regularly happens when using intermittent catheter.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention is unknown.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.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: instructions for intermittent catheters: 1.Always wash hands prior to use.2.Open the catheter package by peeling the tab downwards with the aid of the ends of the package.3.For males: a.Get yourself into a comfortable position.Clean the opening of the urethra ¿ and the surrounding area.Wash your hands again.B.Remove the catheter from the pouch, holding the funnel end with the dominant hand.Lubricate the catheter tip with a sterile water-soluble lubricant.Ensure the tip and the first 6¿ (15 cm) of the catheter are lubricated.Insert the catheter tip into the urethral opening, allowing it to pass gently into the bladder until urine begins to flow.Advance the catheter about another inch.Note: if you are using a coude tip catheter, the raised notch on the catheter funnel will indicate the orientation in which the tip curves upward.Ensure that the coude indicator notch is facing upwards during insertion.4.For females: a.Get yourself into a comfortable position and wash around the urethral opening, spreading the labia and wiping from front to back using an alcohol-free wet wipe or soap and water.(wiping from back to front can spread bacteria from the perineum and should be avoided.) b.Wash your hands again and remove the catheter from the pouch, holding the funnel end.Lubricate the catheter tip with a sterile water-soluble lubricant.Ensure the tip and the first 2¿ (5 cm) of the catheter are lubricated.Spread apart the labia with the non-dominant hand.With the dominant hand, insert the catheter tip into the urethral opening, allowing it to pass gently up into the bladder until urine begins to flow.Advance the catheter about another inch.5.When urine stops flowing, slowly begin to withdraw the catheter.It is recommended to slowly rotate the catheter during withdrawal, stopping each time urine begins to flow.Check the color, odor and clarity of the urine.Any changes may need to be reported to a health care professional.6.Finish by disposing of the catheter and its packaging.Wash your hands with soap and water, just as you would normally do after using the toilet.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.Correction: udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that customer was treated for urinary tract infection.Customer informed this due to something that regularly happens when using intermittent catheter.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention is unknown.

• 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: 21374195
• Report Number: 1018233-2025-00856
• Device Sequence Number: 3849837
• Product Code: GBM
• UDI-Device Identifier: 06948796203844
• UDI-Public: (01)06948796203844
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 04/22/2025
• Report Date (Section F): 01/29/2025

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 Catalogue Number: BUC14M
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/21/2025
• Event Location: Other
• Date Report to Manufacturer: 01/29/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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