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

Model Number	0170SI18
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
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 catheter fell out and patient returned to the office following call, it was noted that the catheter that was originally placed was not inflated with water at the time of removal.Patient had a new catheter placed during second visit.10 ml of sterile water were placed in the port of the catheter, which would result in the balloon being filled in the bladder and filled the balloon external from the patient and the water did not leak out of the balloon.Even hours after the patient left.There was no obvious reason as to why the catheter fell out of the patient.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to a inflation or drainage lumen wall perforated.It was unknown whether the device had met relevant specifications.The product was used for the treatment purposes.It was unknown whether the product had caused the reported failure.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: "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: a, e, 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.The device was not returned.
Event or Problem Description
It was reported that the catheter fell out and the patient returned to the office following the call and noted that the catheter was originally placed was not inflated with water at the time of removal.The patient had a new catheter placed during the second visit.10 ml of sterile water was placed in the port of the catheter which would result in the balloon being filled in the bladder and filled the balloon external from the patient and the water did not leak out of the balloon even hours after the patient left.There was no obvious reason as why the catheter fell out of the patient.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.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.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: "to deflate catheter balloon: gently insert a 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." the device was not returned.
Event or Problem Description
It was reported that the catheter fell out and the patient returned to the office following the call and noted that the catheter was originally placed was not inflated with water at the time of removal.The patient had a new catheter placed during the second visit.10 ml of sterile water was placed in the port of the catheter which would result in the balloon being filled in the bladder and filled the balloon external from the patient and the water did not leak out of the balloon even hours after the patient left.There was no obvious reason as why the catheter fell out of the patient.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11509455
• Report Number: 1018233-2021-01351
• Device Sequence Number: 14789703
• Product Code: EZL
• UDI-Device Identifier: 00801741025358
• UDI-Public: (01)00801741025358
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2021

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: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Model Number: 0170SI18
• Device Catalogue Number: 0170SI18
• Device Lot Number: NGES3475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 06/07/2021; 11/18/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 06/29/2021; 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2020
• 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