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

Model Number 119416M

Device Problem Dent in Material (2526)

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

Event Date 04/23/2022

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 the foley catheter did not inflate properly and the customer cut the foley catheter to remove it.And the catheter was placed at the beginning of the case and there was no urine that had come back and the foley catheter balloon was inflated to 10 ml.The representative confirmed that the balloon was not in the bladder, possibly in the urethra/perineum.While removing the foley catheter, it was found to be defective and appeared to be more oval than the usual round form.

Manufacturer Narrative

The reported event was inconclusive because of poor sample condition.A photo sample was returned of a 3-way foley, temp sensing catheter.The catheter was noted to have been cut into 3 pieces during removal.The inflation arm was cut off, and the trifurcation was cut from the catheter shaft.The balloon was noted to be deflated in the photo.Unable to determine an asymmetric balloon from the photo provided.It is unknown whether the device had met relevant specifications.It was not specified for what purpose the device was used for, but it can be used for both diagnostic and treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be, "operator error (multiple snip) or work insufficiently dried".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "inflate catheter balloon using entire 10cc of sterile water provided in the prefilled syringe note: use of less than 10cc can result in asymmetrically inflated balloon" correction: g 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 the foley catheter did not inflate properly and the customer cut the foley catheter to remove it.And the catheter was placed at the beginning of the case and there was no urine that had come back and the foley catheter balloon was inflated to 10 ml.The representative confirmed that the balloon was not in the bladder, possibly in the urethra/perineum.While removing the foley catheter, it was found to be defective and appeared to be more oval than the usual round form.

• Brand Name: BARDEX® LUBRICATH® 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: 14454475
• MDR Text Key: 292179361
• Report Number: 1018233-2022-03931
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741046148
• UDI-Public: (01)00801741046148
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• 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: 07/05/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 119416M
• Device Catalogue Number: 119416M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/22/2022
• 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