MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER; UNKNOWN LATEX FOLEY CATHETER

Device Problem Incorrect Measurement (1383)

Patient Problem Pain (1994)

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that there was a hole just distal to the three-way port of the foley catheter, so the irrigants were squirting out.Stated that the sample was not available since it was with the patient, and it was discarded.Per follow up via email received on (b)(6) 2023, it was stated that they had three incidents at the hospital where 22french silicon 3 ways catheters were placed.Once the cbi was started it was noticed that water was gushing out of the sides due to a hole.In terms of impact, the hole in the catheter would break sterility.It was also stated that it was painful for patients to have catheters replaced especially one as large as a 22french catheters.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be wrong product size selected/ amplifier card faulty/wrong setting of drying parameter and etc.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to review the labelling due to unknown product code.Although the product family was unknown, the foley catheter ifus are found to be adequate based on past reviews.H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text: the device was not returned.

Event Description

It was reported that there was a hole just distal to the three-way port of the foley catheter, so the irrigants were squirting out.Stated that the sample was not available since it was with the patient, and it was discarded.Per follow up via email received on 03feb2023, it was stated that they had three incidents at the hospital where 22french silicon 3 ways catheters were placed.Once the cbi was started it was noticed that water was gushing out of the sides due to a hole.In terms of impact, the hole in the catheter would break sterility.It was also stated that it was painful for patients to have catheters replaced especially one as large as a 22french catheters.Per additional information received via email on 03mar2023, it was reported that the another catheter with a hole was found today.They currently had 8 and a half boxes full of 22fr silicon 3 way catheters and they were no longer feel comfortable using these catheters.The hole was small and on the third port section of the tube and very distal and just proximal to the bifurcation.We only see the hole once the cbi irrigant was turned on and it squirts out.In terms of patient care, exchanging the catheter was painful and increase their risk of developing a urinary tract infection.No medical intervention was reported.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN LATEX 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: 16435907
• MDR Text Key: 310283862
• Report Number: 1018233-2023-01185
• Device Sequence Number: 1
• Product Code: EZC
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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