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

Model Number	423716
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Complaint, Ill-Defined (2331); Hematuria (2558)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of 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 bard.The device was not returned.
Event or Problem Description
It was reported that the catheter was too stiff and the patient experienced difficulty inserting the catheter.It was noted that the he patient had been feeling sick for a few days and went to the emergency room after experiencing blood in his urine and a fever following this event with the catheter.The patient was diagnosed with a urinary tract infection and remained in the hospital for a period of three days where he was treated with antibiotics.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "bard® clean-cath® 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." (b)(4).The device was not returned.
Event or Problem Description
It was reported that the catheter was too stiff and the patient experienced difficulty inserting the catheter.It was noted that the he patient had been feeling sick for a few days and went to the emergency room after experiencing blood in his urine and a fever following this event with the catheter.The patient was diagnosed with a urinary tract infection and remained in the hospital for a period of three days where he was treated with antibiotics.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: COUDE INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7033560
• Report Number: 1018233-2017-05917
• Device Sequence Number: 799456
• Product Code: KOD
• UDI-Device Identifier: 00801741038884
• UDI-Public: (01)00801741038884
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: 423716
• Device Catalogue Number: 423716
• Device Lot Number: NGBS0950
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/29/2018
• 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: Hospitalization; Required Intervention