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

Model Number	2551H20
Medical Device Problem Codes	Decrease in Pressure (1490); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter was placed after surgery and on the next day, the catheter fell out of the patient.The forceps was not used.Per follow-up information received via ibc on 10-may-2022, stated that there was no visible damage in the returned sample and there was no impact to the patient.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event is unconfirmed as the problem could not be reproduced.The 3 way foley catheter was returned without the original packaging.Photo samples were submitted and no signs of damage were noted from the photos.The physical sample was visually inspected and again no signs of damage were noted.The balloon was inflated with 50cc di water using a luer lock syringe and was noted to inflate concentrically without issues.The catheter was left undisturbed for 10 minutes and no signs of leakage was noted.The balloon deflation without issues.The sample would have passed functional leak testing.The device was used for treatment purposes.The device history record review and labeling review was not required as the reported event was unconfirmed.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.
Event or Problem Description
It was reported that the foley catheter was placed after surgery and on the next day, the catheter fell out of the patient.The forceps was not used.Per follow-up information received via ibc on 10may2022, stated that there was no visible damage in the returned sample and there was no impact to the patient.

• Brand Name: BARDEX® LUBRICATH® HEMATURIA FOLEY CATHETER
• Common Device Name: HEMATURIA 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14407530
• Report Number: 1018233-2022-03786
• Device Sequence Number: 12134770
• Product Code: KOD
• UDI-Device Identifier: 00801741025143
• UDI-Public: (01)00801741025143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• 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): 09/09/2022

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: 04/30/2026
• Device Model Number: 2551H20
• Device Catalogue Number: 2551H20
• Device Lot Number: MCFQ0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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