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

Device Problem Device Handling Problem (3265)

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

Event Date 05/17/2022

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 last two times the patients from the operating room with foley catheters which were placed in the operating room, the foley balloons have been underinflated.Both times the foley was not draining well (no to minimal uop) and when staff checked the foley balloon it did not have the amount of sterile water labeled on the foley.After fully inflating the balloon, the drainage was improved.For example, in patient 1 case the foley called for 3ml of sterile water, when they checked the balloon only had 2.4 ml in it.Additionally, the manufacturer guidelines in the addendum of their foley policy stated that the bard brand foley balloons should be overinflated to aid in adequate drainage, and per policy a 3ml bard foley balloon should have 5 ml of sterile water in it.In both instances they have talked with multiple nurses on the floor and there seemed to be a lack of knowledge of our policy of overinflating bard foley balloons.Also, they have noticed some of the foleys currently stocked were bard brand and some were not, so it would be great to get clarification on if all foleys balloons regardless of brand were supposed to be overinflated or just bard brand, and then how to tell the difference between different brands, as the potential for error seems high if different brands of the same size foleys call for different inflation practices.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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 the last two times the patients from the operating room with foley catheters which were placed in the operating room, the foley balloons have been underinflated.Both times the foley was not draining well (no to minimal uop) and when staff checked the foley balloon it did not have the amount of sterile water labeled on the foley.After fully inflating the balloon, the drainage was improved.For example, in patient 1 case the foley called for 3ml of sterile water, when they checked the balloon only had 2.4 ml in it.Additionally, the manufacturer guidelines in the addendum of their foley policy stated that the bard brand foley balloons should be overinflated to aid in adequate drainage, and per policy a 3ml bard foley balloon should have 5 ml of sterile water in it.In both instances they have talked with multiple nurses on the floor and there seemed to be a lack of knowledge of our policy of overinflating bard foley balloons.Also, they have noticed some of the foleys currently stocked were bard brand and some were not, so it would be great to get clarification on if all foleys balloons regardless of brand were supposed to be overinflated or just bard brand, and then how to tell the difference between different brands, as the potential for error seems high if different brands of the same size foleys call for different inflation practices.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14631060
• MDR Text Key: 293546724
• Report Number: 1018233-2022-04460
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• 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: 08/17/2022
• 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