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

Catalog Number 165816

Device Problem Failure to Infuse (2340)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that customer had an occurrence earlier this month where the balloon would not inflate, and they had to use another kit.Stated the appearance of the catheter that attached to the drain looked old and miscolored.Per customer via email on 13mar2024, it was reported that the product never touched the patient and there was no patient involvement.

Event Description

It was reported that customer had an occurrence earlier this month where the balloon would not inflate, and they had to use another kit.Stated the appearance of the catheter that attached to the drain looked old and miscolored.Per customer via email on (b)(6) 2024, it was reported that the product never touched the patient and there was no patient involvement.

Manufacturer Narrative

The reported event is unconfirmed.Visual evaluation noted received 1 silicone foley catheter with bag attached and syringe returned.Upon inspection catheter appears to be normal color and texture and coloring is present due to silver alloy coating.Inflated balloon using returned syringe with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).And allowed it to rest.Balloon passively deflated within one minute no difficulties.Inflated balloon within house luer lock syringe with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).And allowed it to rest.Balloon passively deflated within one minute no difficulties.Dissected balloon and it was found that the notch was cut as intended.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.Labelling review is not required as the reported event is unconfirmed.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.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18948865
• MDR Text Key: 338358770
• Report Number: 1018233-2024-01490
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• 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,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 165816
• Device Lot Number: NGHY2944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/21/2024
• 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