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

Catalog Number	802514
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
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.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 they got two returns of intermittent catheters one for 802516 and another for 802514.The patient with material# 802514 said the ends were too big on their shipment with lot# nggt5344.The patient with material# 802516 said that the catheter came to them were super thick and they sent back catheter with lot# nggu0960, compared to what they currently have in the slot lot# nghy2643.The color was noticeably different so it was possible it could be a different form of rubber.The darker red they sent back had an expiration of 28feb2027 and they noticed the eyelet was smaller on the darker one.The ones they currently had were a lighter red with expiration of 30apr2028 so whatever they received was an older manufacture date, so it was possible bard had changed something and again it did appear the eyelet hole was bigger on the lighter color.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "operator error".However, there was insufficient information to confirm this potential root cause.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labeling could not have prevented the reported failure.Correction: d.Udi format updated with available product information per gudid.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 they got two returns of intermittent catheters one for 802516 and another for 802514.The patient with material# 802514 said the ends were too big on their shipment with lot# nggt5344.The patient with material# 802516 said that the catheter came to them were super thick and they sent back catheter with lot# nggu0960, compared to what they currently have in the slot lot# nghy2643.The color was noticeably different so it was possible it could be a different form of rubber.The darker red they sent back had an expiration of 28feb2027 and they noticed the eyelet was smaller on the darker one.The ones they currently had were a lighter red with expiration of 30apr2028 so whatever they received was an older manufacture date, so it was possible bard had changed something and again it did appear the eyelet hole was bigger on the lighter color.Per customer via email response on 24jun2024, it was reported that the product was used on a patient and the defect was also noticed before use.No patient harm was reported.It was unknown whether the catheter and eyelet dimensions were under specification.The material was too thick, and rigid compared to other lots.

• Brand Name: BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER
• Common Device Name: URETHRAL 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19632316
• Report Number: 1018233-2024-03823
• Device Sequence Number: 15303853
• Product Code: KOD
• UDI-Device Identifier: 00801741039041
• UDI-Public: (01)00801741039041(11)220804(17)270228(10)NGGT5344
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: Health Professional
• Device Catalogue Number: 802514
• Device Lot Number: NGGT5344
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2022
• 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