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

Model Number 0165L18

Device Problem Material Puncture/Hole (1504)

Patient Problems Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/17/2022

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 issues the nurses had lately was that they inserted 10ml into the bulb then when the foley catheter was change and the fluid was withdrawn, there was only 6-8ml in it and frequently it has looked like urine in the syringe.This had happened multiple times, not just with home patients but patients here in the house also.And stated that they have had another catheter that did the same thing.This catheter was removed on the 30th day and the syringe had only 7.5 ml of orange looking fluid in it.The kits that they have here were latex catheter.The nurse that staff was talking with today said that all of our patients were having spasms, and many seem to have a slight crusty discharge (which was new for bard catheter).Nurse changed them monthly or more frequently if the situation warrants.It did seem like the issue with the fluid in the bulb was happening on most of the catheters that they insert since, and the discoloration was also happening on most.Nurse said that they changed one on sunday and that it was not discolored but there was not much in the bulb and was only able to get about 6 ml back when deflating the bulb.Stated that this was in relation to the surestep foley tray system, bardex lubricath foley catheter tray.The issue that they have had multiple times was that they insert the catheter and usually keep it in their patients for about a month.On insertion, they instill the full 10ml of normal saline from the syringe provided and then when the staff remove the foley, they were not able to get the full 10ml back.It usually had only about 7ml or less and the fluid was discolored.The staff have reported to that it was from both the 16 fr and the 18fr catheter.Normally their staff have preferred the bard catheter to any others that they have used, and they worked well but they have been reporting that the patients seem to have increased spasms with them.No medical intervention was reported.

Event Description

It was reported that the issues the nurses had lately was that they inserted 10ml into the bulb but when tried to withdraw the fluid to change the catheter, it was noted that there were only 6-8ml in it.Also, it looked like urine in the syringe.They stated that this issue had happened multiple times.It was not just with the home patients, they also experienced with the patient here in the house.They had another catheter that did the same thing.On 30th day from insertion the catheter was removed, and the syringe had only 7.5 ml of orange looking fluid in it.The kits that they have were latex catheters.The nurse to whom they were talking with today sated that all of our patients were having spasms, and many seem to have a slight crusty discharge (which was new for bard catheter).They used to change the catheters monthly or more frequently if the situation warrants.It seems like fluid issue in the bulb was happening on most of the catheters that they currently inserting and the discoloration also occurring on most of it.The nurse said that they changed one on sunday and noted that it was not discolored but there was not much fluid on the bulb.They were only able to get about 6 ml back when deflating the bulb.Per information received on 11nov022, the customer stated that this was in relation to the surestep foley tray system, bardex lubricath foley catheter tray.The issue that they have had multiple times is that they insert the catheter and usually keep it in their patients for about a month.During the insertion, they instilled the full 10 ml of normal saline from the syringe provided.When the staff removes the foley, they were not able to get the full 10 ml back.It usually has only about 7ml or less and the fluid was discolored.The staff reported that it was from both the 16fr and 18 fr catheters.Normally they prefer bard catheters to any others that they have used, and they also work well but they have been reporting that the patient seem to have increased spasms with them.No medical intervention was reported.

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 the issues the nurses had lately was that they inserted 10ml into the bulb but when tried to withdraw the fluid to change the catheter, it was noted that there were only 6-8ml in it.Also, it looked like urine in the syringe.They stated that this issue had happened multiple times.It was not just with the home patients, they also experienced with the patient here in the house.They had another catheter that did the same thing.On 30th day from insertion the catheter was removed, and the syringe had only 7.5 ml of orange looking fluid in it.The kits that they have were latex catheters.The nurse to whom they were talking with today sated that all of our patients were having spasms, and many seem to have a slight crusty discharge (which was new for bard catheter).They used to change the catheters monthly or more frequently if the situation warrants.It seems like fluid issue in the bulb was happening on most of the catheters that they currently inserting and the discoloration also occurring on most of it.The nurse said that they changed one on sunday and noted that it was not discolored but there was not much fluid on the bulb.They were only able to get about 6 ml back when deflating the bulb.Per information received on 11nov022, the customer stated that this was in relation to the surestep foley tray system, bardex lubricath foley catheter tray.The issue that they have had multiple times is that they insert the catheter and usually keep it in their patients for about a month.During the insertion, they instilled the full 10 ml of normal saline from the syringe provided.When the staff removes the foley, they were not able to get the full 10 ml back.It usually has only about 7ml or less and the fluid was discolored.The staff reported that it was from both the 16fr and 18 fr catheters.Normally they prefer bard catheters to any others that they have used, and they also work well but they have been reporting that the patient seem to have increased spasms with them.No medical intervention was reported.

Manufacturer Narrative

The reported event is unconfirmed as the device met specifications.Inspected the exterior of the sample and did not find any evidence of a failure that would support the reported event.Inflated with air while submerged in water and noted no air bubbles leaking from the catheter.The balloon was fully inflated with no signs of leaking.The device meets specifications as it would pass functional leak testing.The device was used for treatment purposes.As the reported event is unconfirmed, a dhr review is not required.As the reported event is unconfirmed, a label/packaging review is not required.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.

• Brand Name: BARDEX® LUBRICATH® 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: 15787521
• MDR Text Key: 307588751
• Report Number: 1018233-2022-08712
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017490
• UDI-Public: (01)00801741017490
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0165L18
• Device Catalogue Number: 0165L18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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