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

Catalog Number	01267522
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
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 the foley catheter could not be used because it did not have a cap.Per additional information via email from ibc on 01apr2024, this would be the cap that should be on the inflation valve.
Event or Problem Description
It was reported that the foley catheter could not be used because it did not have a cap.Per additional information via email from ibc on (b)(6) 2024, this would be the cap that should be on the inflation valve.
Additional Manufacturer Narrative
The reported event is unconfirmed- product met specifications.Photo: received four (4) photo samples.All photo samples showcase an overview of foley catheter and its packaging.Visual: received one (1) foley catheter with packaging label.Visual inspection noted inflation cap on catheter.No root cause could be found because the reported event was unconfirmed.As the reported event is unconfirmed a dhr review is not required.However, a dhr was completed before unconfirming the event.As the reported event is unconfirmed a labeling review is not required.Correction: d udi format updated with available product information per gudid.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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL
• 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: 19124585
• Report Number: 1018233-2024-02167
• Device Sequence Number: 7629158
• Product Code: EZC
• UDI-Device Identifier: 00801741018817
• UDI-Public: (01)00801741018817(11)201016(17)250131(10)NGEV3054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 01267522
• Device Lot Number: NGEV3054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2020
• 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