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

Model Number	265716
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage).The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿recommended inflation capacities: 3cc balloon: use 5cc sterile water, 5cc balloon: use 10cc sterile water, 15cc balloon: use 20cc sterile water, 20cc balloon: use 25cc sterile water, 30cc balloon: use 35cc sterile water, 40cc balloon: use 45cc sterile water, 75cc balloon: use 80cc sterile water.Do not exceed recommended capacities.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use 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 this fails, contact an adequately trained professional for assistance, as directed by hospital protocol.¿.
Event or Problem Description
It was reported that the urologist was unable to deflate the balloon in order to extract it from the foot.The urologist said the patient never wanted to use bard brand catheters again.The urologist kept the other catheter on hand, so, the patient could not used it.

• Brand Name: BARD 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: 12283126
• Report Number: 1018233-2021-04726
• Device Sequence Number: 14618730
• Product Code: EZC
• UDI-Device Identifier: 00801741039591
• UDI-Public: (01)00801741039591
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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: Health Professional
• Device Model Number: 265716
• Device Catalogue Number: 265716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/05/2021
• 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