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

Model Number 119112

Device Problem Difficult to Remove (1528)

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

Event Date 01/05/2022

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 it was difficult to remove the water from foley catheter during the pretest.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The reported failure is within specification as the reported failure could not be reproduced.The product was not used for patient treatment or diagnosis.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.Visual evaluation of the returned sample noted temp sensing foley catheter.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 5.5 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).The balloon rested with no observed leaks and passively deflated in 1 min 14.58 sec with no issues or cuffing noted.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that it was difficult to remove water from foley catheter during pretest.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE-SENSING 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: 13541444
• MDR Text Key: 285677271
• Report Number: 1018233-2022-00647
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046018
• UDI-Public: (01)00801741046018
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 119112
• Device Catalogue Number: 119112
• Device Lot Number: NGEX1718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• 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