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

Model Number	123612A
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
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 there was no urine flow when the nurse inserted catheter into patient.It was also stated that it was attempted twice before opening another piece and the catheter could be obstructed as feedback.Foley catheter was contaminated with urine and blood.
Event or Problem Description
It was reported that there was no urine flow when the nurse inserted catheter into patient.It was also stated that it was attempted twice before opening another piece and the catheter could be obstructed as feedback.Foley catheter was contaminated with urine and blood.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.Based on photo sample attached, no visual defect observed.Unable to perform functional testing on returned sample since photo sample received is inadequate to perform evaluation.Potential root cause for this failure mode could be user related (example: salt accumulation)/block drainage lumen/no drainage eye).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." 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.

• 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 GA 30014
• MDR Report Key: 10542148
• Report Number: 1018233-2020-05955
• Device Sequence Number: 11531498
• Product Code: KOD
• UDI-Device Identifier: 00801741095177
• UDI-Public: (01)00801741095177
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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: Other
• Device Expiration Date: 12/28/2023
• Device Model Number: 123612A
• Device Catalogue Number: 123612A
• Device Lot Number: MYDT3014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1