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

Model Number	0166SI20
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 foley catheter was removed from the patient because it was not draining.Per additional information received from the complainant via email on 26 oct 2019, the catheter was irrigated and there was urine return.
Event or Problem Description
It was reported that the foley catheter was removed from the patient because it was not draining.Per additional information received from the complainant via email on (b)(6) 2019, the catheter was irrigated and there was urine return.
Additional Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduce.The evaluation conducted showed that the flow rate for the returned sample had met the minimum requirement (100ml/min).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: " since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.After placement of the catheter, confirm urinary flow through the catheter.When urinary flow cannot b noted, confirm that the catheter is neither occluded nor broken.If the problem is still observed, consider catheter replacement.".

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9194262
• Report Number: 1018233-2019-06509
• Device Sequence Number: 458694
• Product Code: MJC
• UDI-Device Identifier: 00801741016868
• UDI-Public: (01)00801741016868
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019

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: 09/28/2023
• Device Model Number: 0166SI20
• Device Catalogue Number: 0166SI20
• Device Lot Number: 8PB138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1