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

Model Number	73022SI
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/02/2022
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 nurse had deflated the balloon and attempted to remove foley catheter several times without success.About an inch of the foley was stuck in the penis.It was stated that the nurse had called for help and got a second opinion before calling the doctor.It was a non-latex 22 fr foley catheter that sometimes had a ridge near the balloon.After the nurse came to the patient to pull it, they found the balloon had deflated and the plastic had folded over on itself instead of lying flat.Also stated that caused pain for the patient who had to sit with it at the tip of the penis for approximately 40 minutes while staff troubleshoot the problem.Doctor had to tug on the catheter firmly until it popped out.
Additional Manufacturer Narrative
The reported event was inconclusive due to the condition of the samples received.Although an exact root cause could not be determined a potential root cause could be balloon material does not shrink quickly enough.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: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." correction: d, g, 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 nurse had deflated the balloon and attempted to remove foley catheter several times without success.About an inch of the foley was stuck in the penis.It was stated that the nurse had called for help and got a second opinion before calling the doctor.It was a non-latex 22 fr foley catheter that sometimes had a ridge near the balloon.After the nurse came to the patient to pull it, they found the balloon had deflated and the plastic had folded over on itself instead of lying flat.Also stated that caused pain for the patient who had to sit with it at the tip of the penis for approximately 40 minutes while staff troubleshoot the problem.Doctor had to tug on the catheter firmly until it popped out.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE 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: 15779333
• Report Number: 1018233-2022-08696
• Device Sequence Number: 4923936
• Product Code: MJC
• UDI-Device Identifier: 00801741025518
• UDI-Public: (01)00801741025518
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K070558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: 04/30/2025
• Device Model Number: 73022SI
• Device Catalogue Number: 73022SI
• Device Lot Number: NGES0161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2020
• 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: Male