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

Model Number	0168L14
Medical Device Problem Codes	Material Fragmentation (1261); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2022
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.The information provided by bd 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 bd.
Event or Problem Description
It was reported that the foley catheter was removed from the patient and was straight catheterized the previous day and found that the catheter was missing about 3/4 inch of its tip.Stated that urology did not find it in the patient's bladder and felt like that may have been present from the beginning due to a manufacturing default.Also stated that they checked the supplies in pacu and psu 3 and they all appeared to be fully intact.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿operator error¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.Sterile unless package is opened or damaged warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Correction: g.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the foley catheter was removed from the patient and was straight catheterized the previous day and found that the catheter was missing about 3/4 inch of its tip.Stated that urology did not find it in the patient's bladder and felt like that may have been present from the beginning due to a manufacturing default.Also stated that they checked the supplies in pacu and psu 3 and they all appeared to be fully intact.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14655250
• Report Number: 1018233-2022-04529
• Device Sequence Number: 4918936
• Product Code: EZC
• UDI-Device Identifier: 00801741017810
• UDI-Public: (01)00801741017810
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 12/31/2024
• Device Model Number: 0168L14
• Device Catalogue Number: 0168L14
• Device Lot Number: NGEX2543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2020
• 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