MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP; INTERMITTENT CATHETER

Catalog Number	010116
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that by using intermittent catheter customer experienced bleeding and collapsing when put into urinary tract.It was an ongoing issue.No medical intervention was reported.Per follow up via phone on 01oct2024, it was reported that the catheters from the malaysian facility did not work.Also stated that the tips collapsed which caused bleeding and did not seek medical attention.Per sample form received on 25oct2024, it was reported that the catheters collapse, fold over on inlet hole upon attempted insertion, in the process it pinches urinary tract walls cased.Bleeding, patient did feel it and it was impossible to drain the bladder.
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 unconfirmed because the reported failure could not be reproduced.The returned device was functionally tested and the product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A potential root cause for this failure mode could be drainage eyes too large causing weak tip.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: indications for use: for urological use only: single use.Single patient use.Do not reuse do not use if package is open or damaged.Sterilized using ethylene oxide storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: this product contains natural rubber latex which may cause allergic reactions.Warnings: on latex and red rubber catheters, do not use ointments or lubricants having a petroleum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristic of the device, which may lead to failure, and/or to injury, illness or death of the patient.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 regulation.Adverse reactions: urinary tract infection; bleeding from urethra; irritation of the urethra.Instruction 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.4.Gently insert rounded end of catheter into urethra.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands.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 by using intermittent catheter customer experienced bleeding and collapsing when put into urinary tract.It was an ongoing issue.No medical intervention was reported.Per follow up via phone on 01oct2024, it was reported that the catheters from the malaysian facility did not work.Also stated that the tips collapsed which caused bleeding and did not seek medical attention.Per sample form received on 25oct2024, it was reported that the catheters collapse, fold over on inlet hole upon attempted insertion, in the process it pinches urinary tract walls cased.Bleeding, patient did feel it and it was impossible to drain the bladder.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 20693889
• Report Number: 1018233-2024-07233
• Device Sequence Number: 7196885
• Product Code: KOD
• UDI-Device Identifier: 00801741029875
• UDI-Public: (01)00801741029875(11)240222(17)280630(10)NGJP1139
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 010116
• Device Lot Number: NGJP1139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 165 KG
• Patient Race: White