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

Model Number	123520A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be could be user related (example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage).The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.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 served.If this fails, contact an adequately trained professional for assistance, as directed by hospital protocol." the device was not returned.
Event or Problem Description
It was reported that when the foley catheter was removed, the balloon was not smooth and could not be completely eliminated.It was stated that there was still 1 to 2ml in the balloon.It was mentioned that the customer cut off the catheter.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13795636
• Report Number: 1018233-2022-01362
• Device Sequence Number: 5032763
• Product Code: EZC
• UDI-Device Identifier: 00801741095115
• UDI-Public: (01)00801741095115
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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 Model Number: 123520A
• Device Catalogue Number: 123520A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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