MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD CLEAN-CATH INTERMITTENT CATHETER

Model Number	423716
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
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.
Event or Problem Description
It was reported that the coude intermittent catheter was hard to insert since it was not curved enough.
Event or Problem Description
It was reported that the coude intermittent catheter was hard to insert since it was not curved enough.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure mode could be operator error or machine mulfunction (ex: insufficient cooling time, pressure gauge out of calibration or improper adjustment of air purging nozzle).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: ¿length: for urological use only.To use: insert rounded end of catheter.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Do not reuse.Do not resterilize.Do not use if package is damaged.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ 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 CLEAN-CATH INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11870612
• Report Number: 1018233-2021-02982
• Device Sequence Number: 19633853
• Product Code: KOD
• UDI-Device Identifier: 00801741038884
• UDI-Public: (01)00801741038884
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 423716
• Device Catalogue Number: 423716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other