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

Model Number 33620

Device Problems Disconnection (1171); Decrease in Pressure (1490)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2023

Event Type  malfunction  

Event Description

It was reported the foley catheter balloon deflated and came out of the urethra when the doctor returned after they placed it for the first time on the patient.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported the foley catheter balloon deflated and came out of the urethra when the doctor returned after they placed it for the first time on the patient.

Manufacturer Narrative

The reported event was confirmed and the cause was unknown.As it was unknown how the inflation cap/valve came loose and disconnected, this event would be confirmed and the cause was unknown.Although a specific cause could not be determined, a potential root cause for this event could be, "improper tolerancing (fit between the check valve/cap assembly and inflation funnel)".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: "warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter." "visually inspect the product for any imperfections or surface deterioration prior to use." "storage: store catheters at room temperature away from direct exposure to light, preferably in the original box." h11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Type of Device: 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16566079
• MDR Text Key: 311740740
• Report Number: 1018233-2023-01843
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020087
• UDI-Public: (01)00801741020087
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K951103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

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
• Device Operator: Health Professional
• Device Model Number: 33620
• Device Catalogue Number: 33620
• Device Lot Number: NGGV1429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other