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

Catalog Number	802516
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that product was mislabeled.Patient ordered 16 french, which was indicated on box but when opened saw that the catheter was 14 french.Per customer follow up on 03dec2024, it was reported that customer ordered 180 16fr urethral catheters from edgepark.When they received the order, they noticed that the catheters were visibly smaller and stated the size inside the packaging is 14fr, and not the 16fr that they ordered.Customer reached out to edgepark and was told that the company would not replace the catheters or reimburse them.Customer was advised to reach out to the bd claims department to proceed further with a claim.No injury or harm was reported.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted three opened (with original packaging), intermittent latex catheter.Visual inspection of the three sample noted all three catheters were measured at the correct size of 16fr.As indicated on the product packaging.This met specification per component requirement: "dimensions: 5.75¿ x 5.75¿.No root cause could be found because the reported event was unconfirmed.A dhr is not required since the reported failure was unconfirmed.As the reported event is unconfirmed a labeling review is not required.Correction: d, e, h.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 product was mislabeled.Patient ordered 16 french, which was indicated on box but when opened saw that the catheter was 14 french.Per customer follow up on 03dec2024, it was reported that customer ordered 180 16fr urethral catheters from (b)(6).When they received the order, they noticed that the catheters were visibly smaller and stated the size inside the packaging is 14fr, and not the 16fr that they ordered.Customer reached out to (b)(6) and was told that the company would not replace the catheters or reimburse them.Customer was advised to reach out to the bd claims department to proceed further with a claim.No injury or harm was reported.Per sample form received on 06jan2025, it was reported that the catheter 802516 with lot#ngfz2474 was the correct size and worked well.The catheter 802516 with lot#ngjt0580 was smaller and more flexible and did not work at all.It kinked up when introduced into the urethral and would not enter the bladder.

• Brand Name: BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER
• Common Device Name: URETHRAL 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: 20924889
• Report Number: 1018233-2024-07971
• Device Sequence Number: 14775883
• Product Code: KOD
• UDI-Device Identifier: 00801741039058
• UDI-Public: (01)00801741039058(11)240717(17)280630(10)NGJT0580
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 802516
• Device Lot Number: NGJT0580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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