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

Model Number	123620A
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
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 catheters were clogging after two weeks.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was 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.A 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 lot number was unknown; therefore, the device history record could not be reviewed.A review of the device labeling is adequate to prevent the reported event."caution: this product contains natural rubber latex which may cause allergic reactions.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile unless package is opened or damaged warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Do not use if package is opened or damaged.Recommended inflation capacities 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities." 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that catheters were clogging after two weeks.

• 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
• MDR Report Key: 11087758
• Report Number: 1018233-2020-21910
• Device Sequence Number: 11565040
• Product Code: KOD
• UDI-Device Identifier: 00801741095214
• UDI-Public: (01)00801741095214
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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 Model Number: 123620A
• Device Catalogue Number: 123620A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other