MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 ALL SILICONE CATHETER; UNKNOWN SILICONE CATHETER

Device Problem Failure to Infuse (2340)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 customer had couple of concerns about surestep foley catheters they have had recently on their unit.Staffs were reporting that there have been occasions where the balloon did not inflate or deflate on the first, or even second try.Staffs were aware that it was not recommended to blow up the balloon prior to insertion but now that this problem has been discovered were continuing to try it prior to insertion.They were wondered if it did not deflate before they put it in, how could they know it was deflated prior to removal.Stated that the operating room staffs were reporting times that a foley was in place prior to c-section starting but the bladder was full upon opening the abdomen.They have noticed occasionally the bladder was not emptying, even after the baby was born until the foley was manipulated.Per additional information received via email on (b)(6) 2024, it was reported that the earlier in the week a staff member stated that the foley tubing came off the bag as patient was moving it around.Patient was able to reattach and did not save the product.Last week, in the operating room (c-section) the bladder seemed to be fuller than normal with foley in place however the anesthesia team reported foley draining yellow urine.The only specific product they had available was an unused foley that was told that they had problems blowing up the balloon.Now that they had tried several times and played with the product it worked fine.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d,g,h.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 customer had couple of concerns about surestep foley catheters they have had recently on their unit.Staffs were reporting that there have been occasions where the balloon did not inflate or deflate on the first, or even second try.Staffs were aware that it was not recommended to blow up the balloon prior to insertion but now that this problem has been discovered were continuing to try it prior to insertion.They were wondered if it did not deflate before they put it in, how could they know it was deflated prior to removal.Stated that the operating room staffs were reporting times that a foley was in place prior to c-section starting but the bladder was full upon opening the abdomen.They have noticed occasionally the bladder was not emptying, even after the baby was born until the foley was manipulated.Per additional information received via email on 28mar2024, it was reported that the earlier in the week a staff member stated that the foley tubing came off the bag as patient was moving it around.Patient was able to reattach and did not save the product.Last week, in the operating room (c-section) the bladder seemed to be fuller than normal with foley in place however the anesthesia team reported foley draining yellow urine.The only specific product they had available was an unused foley that was told that they had problems blowing up the balloon.Now that they had tried several times and played with the product it worked fine.Per ucc notification received via task on 22apr2024, the customer did not return an all-silicone foley catheter.The customer returned a foley catheter attached to a drain bag (pcn#(b)(4) and pcn#(b)(4)).

Event Description

It was reported that customer had couple of concerns about surestep foley catheters they have had recently on their unit.Staffs were reporting that there have been occasions where the balloon did not inflate or deflate on the first, or even second try.Staffs were aware that it was not recommended to blow up the balloon prior to insertion but now that this problem has been discovered were continuing to try it prior to insertion.They were wondered if it did not deflate before they put it in, how could they know it was deflated prior to removal.Stated that the operating room staffs were reporting times that a foley was in place prior to c-section starting but the bladder was full upon opening the abdomen.They have noticed occasionally the bladder was not emptying, even after the baby was born until the foley was manipulated.Per additional information received via email on 28mar2024, it was reported that the earlier in the week a staff member stated that the foley tubing came off the bag as patient was moving it around.Patient was able to reattach and did not save the product.Last week, in the operating room (c-section) the bladder seemed to be fuller than normal with foley in place however the anesthesia team reported foley draining yellow urine.The only specific product they had available was an unused foley that was told that they had problems blowing up the balloon.Now that they had tried several times and played with the product it worked fine.Per ucc notification received via task on 22apr2024, the customer did not return an all-silicone foley catheter.The customer returned a foley catheter attached to a drain bag (pcn# (b)(4) and pcn# (b)(4) ).

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A potential root cause for this failure mode could be due to "low slurry calcium concentration".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Proper techniques for urinary catheter maintenance: 1) secure the foley catheter.Use the statlock® foley stabilization device if provided.2) maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions.3) maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.4) keep the collection bag below the level of the bladder or hips at all times.5) empty the collection bag regularly using a separate, clean collection container for each.Foley catheter removal: 1) to deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required tomake the syringe ¿stick¿ in the valve.2) allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.3) use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.4) if the balloon will not deflate and if permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.5) should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: UNKNOWN SILICONE 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: 19002937
• MDR Text Key: 339254153
• Report Number: 1018233-2024-01699
• Device Sequence Number: 1
• Product Code: EZL
• 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: 05/23/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/29/2024; 05/22/2024
• Supplement Dates FDA Received: 05/09/2024; 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• 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