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

Catalog Number	010116
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the customer was currently using catheter 010116, three samples provided by urologist.During insertion the patient experienced pain when passing the prostate.They were advised by urologist to soak catheters in dish detergent, rinse, air dry and reuse.Patient was inquiring what came in kit 4a7044.Representative advised patient kit 4a7044 was a 14fr, not the 16fr the patient was currently using.Suggested talking with urologist regarding catheter size change.Also advised catheter 010116 was single use and they did not recommend cleaning and reusing them.Informed patient touchless plus intermittent catheter system (4a7044) contained a lubricated rubber catheter, gloves, povidone iodine swabs to clean then anatomy, a collection bag and an under pad.No medical intervention was reported.
Event or Problem Description
It was reported that the customer was currently using catheter 010116, three samples provided by urologist.During insertion the patient experienced pain when passing the prostate.They were advised by urologist to soak catheters in dish detergent, rinse, air dry and reuse.Patient was inquiring what came in kit 4a7044.Representative advised patient kit 4a7044 was a 14fr, not the 16fr the patient was currently using.Suggested talking with urologist regarding catheter size change.Also advised catheter 010116 was single use and they did not recommend cleaning and reusing them.Informed patient touchless plus intermittent catheter system (4a7044) contained a lubricated rubber catheter, gloves, povidone iodine swabs to clean then anatomy, a collection bag and an under pad.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "outside diameter is too large, rough or irregular shape protrusions".The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: ¿bard® intermittent catheter (latex).Instructions for use: indications for use: for urological use only.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 petrolatum 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 characteristics 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 regulations.Adverse reactions urinary tract infection bleeding from the urethra irritation of the urethra instructions for intermittent catheters: wash your hands thoroughly with soap and water.Remove catheter from the pack.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.Gently insert rounded end of catheter into urethra.When urine stops flowing, remove catheter from urethra.Dispose of catheter in accordance with local rules and regulations.Wash your hands.Caution: federal (u.S.A.) laws restricts this device to sale by or on the order of a physician.¿ 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.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: UROLOGICAL CATHETER COUDE TIP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17754608
• Report Number: 1018233-2023-06799
• Device Sequence Number: 6768303
• Product Code: KOD
• UDI-Device Identifier: 00801741029875
• UDI-Public: (01)00801741029875
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: Health Professional
• Device Catalogue Number: 010116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/03/2023
• 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