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

Catalog Number 119116

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

It was reported that foley catheter could not drain urine at the 10th day.

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 foley catheter could not drain urine at the 10th day.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (with original packaging), used all-silicone temp sensing foley catheter.Visual inspection of the sample noted the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and allowed to drain freely.Flushed the drainage funnel and no blockage observed.With the syringe attached the balloon passively deflated with no issues.No defects noted.No root cause could be found because the reported event was unconfirmed.Dhr is not required since the reported failure was unconfirmed.The investigation is concluded, and no additional action is required at this time.As the reported event is unconfirmed a labeling review is not required.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 TEMPERATURE-SENSING 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: 18409539
• MDR Text Key: 331500976
• Report Number: 1018233-2023-09317
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046032
• UDI-Public: (01)00801741046032
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2024
• Device Catalogue Number: 119116
• Device Lot Number: NGGS2187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• 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