MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER FEMALE LENGTH; 5CC FEMALE LUBRICATH

Model Number	0169L16
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
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 patient felt there was no lubricant while inserting and felt catheter was swelling inside the patient.Also customer had catheter for few days and felt need to take out and supposed there was a change in product.Per follow up via phone on (b)(6) 2021, the customer noted that the catheter starts sticking to the patient inside the urethra after about of week of use and gets worse as time progresses.It was noted that 2 used samples will be sent for evaluation.
Event or Problem Description
It was reported that the patient felt there was no lubricant while inserting and felt catheter was swelling inside the patient.Also customer had catheter for few days and felt need to take out and supposed there was a change in product.Per follow up via phone on (b)(6) 2021, the customer noted that the catheter starts sticking to the patient inside the urethra after about of week of use and gets worse as time progresses.It was noted that 2 used samples will be sent for evaluation.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample.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.A potential root cause for this failure could be coating degradation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter.Visually inspect the product for any imperfections or surface deterioration prior to use." h11: section a through f - 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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER FEMALE LENGTH
• Common Device Name: 5CC FEMALE LUBRICATH
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11510076
• Report Number: 1018233-2021-01366
• Device Sequence Number: 3877000
• Product Code: EZC
• UDI-Device Identifier: 00801741018008
• UDI-Public: (01)00801741018008
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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 Expiration Date: 07/31/2022
• Device Model Number: 0169L16
• Device Catalogue Number: 0169L16
• Device Lot Number: NGDY1045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2019
• 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: Unknown