MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

Catalog Number	802520
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had been using the intermittent catheters since the 1980s and the problem was not noticed until approximately 1 1/2 ¿ 2 years ago.They contacted the company and got jailed around for a year on (b)(6) 2022.They sent a few catheters using the packaging material they sent to them.The issue was the tips of the catheters were not the same size and they should be.Package showed the size and description.The tips were different as it affected their results during usage.If the tip was smaller they were successful and if it¿s layer was fuller they were not, which a waste of time, money and their overall wellbeing.They called and was told still being investigated, a few months later, they got the same comment, then a few months later they were told the case was closed, but, would reopen a new case.On 24oct2023, they got an email mentioning their complaint but their conclusion was the catheter was not wasted.It was like they did not investigate the actual problem.Also stated that the customer was having over 30 years experience using this catheters and knew the tips were not all the same, like they noted previously, the tips should all be smaller.The problem was on the manufacturing end.The packaging stated what it was when it was not.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the customer had been using the intermittent catheters since the 1980s and the problem was not noticed until approximately 1 1/2 ¿ 2 years ago.They contacted the company and got jailed around for a year on (b)(6) 2022.They sent a few catheters using the packaging material they sent to them.The issue was the tips of the catheters were not the same size and they should be.Package showed the size and description.The tips were different as it affected their results during usage.If the tip was smaller they were successful and if it¿s layer was fuller they were not.They called and was told still being investigated, a few months later, they got the same comment, then a few months later they were told the case was closed, but, would reopen a new case.On 24oct2023, they got an email mentioning their complaint but their conclusion was the catheter was not wasted.It was like they did not investigate the actual problem.Also stated that the customer was having over 30 years experience using this catheters and knew the tips were not all the same, like they noted previously, the tips should all be smaller.The problem was on the manufacturing end.The packaging stated what it was when it was not.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "operator error".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.A labeling review was not performed because labeling could not have prevented the reported failure.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.H3 other text: the device was not returned.

• Brand Name: BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18400597
• Report Number: 1018233-2023-09272
• Device Sequence Number: 19526326
• Product Code: KOD
• UDI-Device Identifier: 00801741039072
• UDI-Public: (01)00801741039072
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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 Catalogue Number: 802520
• Device Lot Number: NGHR0265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• 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