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

Model Number	2551H22
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
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 water did not come out from the balloon of the foley catheter.
Additional Manufacturer Narrative
The reported event was unconfirmed since the problem could not be reproduced.The device did not fail to meet relevant specifications.The product was used for treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.An amber 3 way foley catheter was returned opened without original packaging.The balloon was inflated with 50 ccs of di water using a luer lock syringe.The balloon inflated concentrically without issue.No leaks were noted.Using a luer lock syringe the balloon was able to be fully deflated without issue.Product meets specification, as it would pass functional leak testing.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed as the reported event was unconfirmed.Corrections: d, h.H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the water did not come out from the balloon of the foley catheter.Per follow up via ibc on 19jan2021, it was unknown how the water removed from the balloon of the foley catheter.

• Brand Name: BARDEX LUBRICATH HEMATURIA FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11232488
• Report Number: 1018233-2021-00133
• Device Sequence Number: 19859668
• Product Code: KOD
• UDI-Device Identifier: 00801741025150
• UDI-Public: (01)00801741025150
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 12/28/2024
• Device Model Number: 2551H22
• Device Catalogue Number: 2551H22
• Device Lot Number: MYDX4522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 10/02/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other