MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD ALL PURPOSE URETHRAL CATHETER

Model Number	0094160
Medical Device Problem Codes	Improper Chemical Reaction (2952); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2021
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 urethral catheter was tacky or very sticky on the insertion tip, and not smooth.The user found the same issue more often.Per follow up information received on 19jan2021, the user did not put lube on the catheter.In other catheter, the user found with the same issue and put lube on it, which was still tacky and caused injury to the patient.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to the chlorine pump failure.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.This would help to prevent the use of a defective catheter." h11: section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the urethral catheter was tacky or very sticky at the insertion tip and not smooth.The user found the same issue more often.Per follow up information received on 19jan2021 the user did not put the lubricity on the catheter.In other catheter the user found with the same issue and put lubricity on it which was still tacky and caused injury to the patient.No medical intervention was reported.

• Brand Name: BARD ALL PURPOSE URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11309423
• Report Number: 1018233-2021-00397
• Device Sequence Number: 3120655
• Product Code: KOD
• UDI-Device Identifier: 00801741034039
• UDI-Public: (01)00801741034039
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 0094160
• Device Catalogue Number: 0094160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 07/09/2021
• 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