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

Catalog Number	165810
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was unconfirmed.It was received 1 all silicone foley catheter.The catheter balloon was inflated with 5 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and no leaks were observed.Catheter concentricity was evidenced 60:40 (within specification) and the catheter rested with no leaks.The inhouse syringe was connected and it was able to return the 5 ml in one minute and 45 seconds however it was evidenced cuffing.No root cause could be found because the reported event was unconfirmed.As the reported event is unconfirmed a dhr review is not required.However, a dhr was completed before unconfirming the event.Labeling review is not required.H11: section a through f - the information provided by bd represents all 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 bd.
Event or Problem Description
It was reported that registered nurse went to remove foley resistance was met, this registered nurse stopped immediately.Urology consulted and en route.When registered nurse went to go examine foley catheter after removed it looked like the balloon was only inflating on one side (pcn# (b)(4) ).Per follow up via email on 20mar2024, the patient experienced temporary pain, but no physical harm.Per sample received on 15apr2024, it was noted that the foley catheter was returned for evaluation (pcn# (b)(4) ).Per notification from investigator on 10may2024, during sample evaluation it was found that the foley catheter balloon was mushroomed (pcn# (b)(4) ).Per follow up response via email on 28may2024, customer called to report that there was minor impact to the patient.The patient had pain but did not seek medical attention.(pcn# (b)(4) ).

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19577906
• Report Number: 1018233-2024-03648
• Device Sequence Number: 17158012
• Product Code: KOD
• UDI-Device Identifier: 00801741029721
• UDI-Public: (01)00801741029721
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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
• Report Date (Section B): 05/29/2024

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 Catalogue Number: 165810
• Device Lot Number: NGHW3690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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