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

Model Number	165810
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
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 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.
Additional Manufacturer Narrative
The reported event was unconfirmed because the device met specifications.No root cause could be found because the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event was unconfirmed a labeling review was not required.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.
Event or Problem 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® PEDIATRIC ALL-SILICONE FOLEY CATHETER
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14021939
• Report Number: 1018233-2022-02035
• Device Sequence Number: 6056664
• Product Code: KOD
• UDI-Device Identifier: 00801741029721
• UDI-Public: (01)00801741029721
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K821745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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 Expiration Date: 04/01/2026
• Device Model Number: 165810
• Device Catalogue Number: 165810
• Device Lot Number: NGFT5821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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