MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD LUBRICATH FOLEY CATHETER

Model Number	33422
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
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 a patient had bypass issues.Supposedly, the lubricath was substituted for the same french/balloon size as originally received; however, there was still urine bypassing.The patient had a significantly enlarged prostate.It was further reported that the patient had prostate cancer and that the insertion issues might be related to this.The medical information lead adds that in her experience bypassing is commonly related to bladder spasms.
Event or Problem Description
It was reported that a patient had bypass issues.Supposedly, the lubricath was substituted for the same french/balloon size as originally received; however, there was still urine bypassing.The patient had a significantly enlarged prostate.It was further reported that the patient had prostate cancer and that the insertion issues might be related to this.The medical information lead adds that in her experience, bypassing is commonly related to bladder spasms.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: d 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the patient had a bypass issue.Supposedly the lubricath was substituted for the same french of balloon size as originally received however there was still urinating through the bypass.The patient had a significant enlarged prostate.It was further reported that the patient had a prostate cancer and the insertion issues might be related to this.The medical information lead added that in the patient experience.The bypass was commonly related to bladder spasms.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met relevant specifications.The product used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to low latex viscosity during the sac dipping.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: "visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities 3cc balloon: use 5 cc sterile water 5cc balloon: use 10 cc sterile water 15cc balloon: use 20 cc sterile water 20cc balloon: use 25 cc sterile water 30cc balloon: use 35 cc sterile water 40cc balloon: use 45 cc sterile water 75cc balloon: use 50 cc sterile water do not exceeded recommended capacities." 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.

• Brand Name: BARD LUBRICATH FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10734325
• Report Number: 1018233-2020-20432
• Device Sequence Number: 4132872
• Product Code: KOD
• UDI-Device Identifier: 00801741020018
• UDI-Public: (01)00801741020018
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

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: 08/28/2024
• Device Model Number: 33422
• Device Catalogue Number: 366724
• Device Lot Number: MYDX0189
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 01/21/2021; 02/18/2021
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 02/04/2021; 03/11/2021
• 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