MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED

Model Number	123512A
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
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 no urine could be drained out by using the foley catheter to the urine bag.(date of event on (b)(6) 2022).Per additional information received on 08aug2022, they were 2 more cases using the same lot having the same problem which was found to be blocked after being used on patient (date of event on (b)(6) 2022 and date of event on (b)(6) 2022).The event occurred in three different patients.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be incorrect parameter setting - blocked drainage eye/lumen or no drainage eye or user related (salt accumulation).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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If the tails, contact an adequately trained professional for assistance as detected by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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 device was not returned.
Event or Problem Description
It was reported that no urine could be drained out by using the foley catheter to the urine bag.(date of event: 28jul2022).Per additional information received on 08aug2022, they were 2 more cases using the same lot having the same problem which was found to be blocked after being used on patient (date of event: 05aug2022 and date of event: 03aug2022).The event occurred in three different patients.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• 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: 15258569
• Report Number: 1018233-2022-06570
• Device Sequence Number: 6688037
• Product Code: EZC
• UDI-Device Identifier: 00801741095078
• UDI-Public: (01)00801741095078
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 03/28/2025
• Device Model Number: 123512A
• Device Catalogue Number: 123512A
• Device Lot Number: MYER0658
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2020
• 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