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

Model Number	1857SI24
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
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 outer foley catheter product packaging listed coude for 1857si24 5-pack ,but the individual items did not, so it might cause customer confusion if separated from the outer package.
Event or Problem Description
It was reported that the outer foley catheter product packaging listed coude for 1857si24 5-pack ,but the individual items did not, so it might cause customer confusion if separated from the outer package.Per additional information received via email on 26oct2022, it was reported that there was no patient harm and the nurses did not know to use it since did not say coude.
Additional Manufacturer Narrative
The reported event is unconfirmed as the product packaging is within specifications.No physical sample was returned, however, a photo sample was submitted.Evaluation of the photo sample noted the unit box with the computer generated label, the label includes "3 way wide lumen open coude".Two individual foley catheters were also pictured in the closed original packaging, the catheter packaging states "2 way wide lumen open tip" with no mention of coude.Though the catheter packaging does not state coude this is still within specifications.As no patient involvement was reported the device was not used though is intended for treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is unconfirmed, a label/packaging review is not required.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 actual/suspected device was inspected.

• Brand Name: BARDEX® I.C. 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: 15649871
• Report Number: 1018233-2022-08050
• Device Sequence Number: 11358173
• Product Code: MJC
• UDI-Device Identifier: 00801741017377
• UDI-Public: (01)00801741017377
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• 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): 03/01/2023

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 Expiration Date: 06/30/2024
• Device Model Number: 1857SI24
• Device Catalogue Number: 1857SI24
• Device Lot Number: NGFV3770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 03/04/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2021
• 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