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

Model Number 165812

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Too Soft/Flexible (4007)

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

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the silicone foley catheters were leaking and dislodging every time they inserted into the patient.This was a transgender patient converting from a female to a male.So, they needed a stiffer or firmer foley for this patient because they need to keep the urethra open for an extended period of time because there were multiple reconstruction surgeries with this transition.Per photo sample provided, it was found that the foley catheter balloons were lopsided which was leading to the issues that customer was expressing.The affected product catalog numbers were 165810 with batch no.Ngft5821, 165812 with batch no.Ngez0706 and 165812 with batch no.Ngfw3722.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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.

Event Description

It was reported that the silicone foley catheters were leaking and dislodging every time they inserted into the patient.This was a transgender patient converting from a female to a male.So, they needed a stiffer or firmer foley for this patient because they need to keep the urethra open for an extended period of time because there were multiple reconstruction surgeries with this transition.Per photo sample provided, it was found that the foley catheter balloons were lopsided which was leading to the issues that customer was expressing.The affected product catalog numbers were 165810 with batch no.Ngft5821, 165812 with batch no.Ngez0706 and 165812 with batch no.Ngfw3722.

• Brand Name: BARDEX® ALL-SILICONE 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14029582
• MDR Text Key: 288808212
• Report Number: 1018233-2022-02067
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029738
• UDI-Public: (01)00801741029738
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

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
• Device Operator: Health Professional
• Device Model Number: 165812
• Device Catalogue Number: 165812
• Device Lot Number: NGFW3722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sex: Transgender