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

Model Number	010114
Medical Device Problem Codes	Nonstandard Device (1420); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
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.The device was not returned.
Event or Problem Description
It was reported that in a box of 12 intermittent catheters only 1 worked and had damaged the patient's urethra which stripped out some of the meat sometimes.Patient stated that in every box they got they only got 3-4 per box and wanted to look into the size of the tube that the curve at the end was way too big.Patient tried to straighten out but said that made them rough and made them useless.When the patient had the bend, it protected the intake from scraping the urethra, a lot of them were rough and sometimes the intake hole was on the opposite side of the curve.Stated that some catheters were flat and some of them were way too big.Customer had cut trying to figure it out.Also the rubber or whatever material the catheters were made of were rough and had bumps.Guessed that there are bumps on the inside as well.Patient stated that some of the catheters have jagged holes and some did not.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 "machine error".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 device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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: 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." the device was not returned.
Event or Problem Description
It was reported that in a box of 12 intermittent catheters only 1 worked and had damaged the patient's urethra which stripped out some of the meat sometimes.Patient stated that in every box they got they only got 3-4 per box and wanted to look into the size of the tube that the curve at the end was way too big.Patient tried to straighten out but said that made them rough and made them useless.When the patient had the bend, it protected the intake from scraping the urethra, a lot of them were rough and sometimes the intake hole was on the opposite side of the curve.Stated that some catheters were flat and some of them were way too big.Customer had cut trying to figure it out.Also the rubber or whatever material the catheters were made of were rough and had bumps.Guessed that there are bumps on the inside as well.Patient stated that some of the catheters have jagged holes and some did not.No medical intervention was reported.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: COUDE INTERMITTENT CATHETER
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15055320
• Report Number: 1018233-2022-05613
• Device Sequence Number: 20162139
• Product Code: KOD
• UDI-Device Identifier: 00801741029868
• UDI-Public: (01)00801741029868
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/05/2022

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 Model Number: 010114
• Device Catalogue Number: 010114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 10/11/2022
• 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