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

Device Problem Difficult to Remove (1528)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "incorrect balloon design (balloon wall thickness excessive)".The dhr review could not be completed because the provided lot number was invalid.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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 silicone indwelling foley catheters were receiving resistance at the end where the balloon sits at the tip of the catheter.The catheter did not want to come out as if the balloon was not deflated, but it showed it was.

Event Description

It was reported that the silicone indwelling foley catheters were receiving resistance at the end where the balloon sits at the tip of the catheter.The catheter did not want to come out as if the balloon was not deflated, but it showed it was.Per follow-up information received on 12apr2024, this was their documentation from the patient's chart.The catheter was still in place.Customer had made a urology appointment for the patient on (b)(6) 2024.In with attending nurse earlier to replace indwelling catheter.Deflated balloon and began to remove catheter.Resistance met at tip of deflated balloon.Indwelling catheter bardex ngfr0597, 14/10 silicone.Notes reveal that catheter was placed (b)(6) 2024.Customer called the manufacturer to see if there was guidance in removing this catheter.Manufacturer recommended deflating the balloon 2 times and attempting to remove catheter.Alerted company that this was done and was recommended to contact the medical provider.Customer called to spaulding (releasing facility) to determine if there had been difficulties with the catheter.They stated that they had to place a 14 fr because the 16 fr would not place.Stated that they placed a silicone catheter because the standard catheter would not place.Customer stated that they would maintain current catheter.

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.H3 other text : the device was not returned.

Event Description

It was reported that the silicone indwelling foley catheters were receiving resistance at the end where the balloon sits at the tip of the catheter.The catheter did not want to come out as if the balloon was not deflated, but it showed it was.Per follow-up information received on 12apr2024, this was their documentation from the patient's chart.The catheter was still in place.Customer had made a urology appointment for the patient on (b)(6) 2024.In with attending nurse earlier to replace indwelling catheter.Deflated balloon and began to remove catheter.Resistance met at tip of deflated balloon.Indwelling catheter bardex ngfr0597, 14/10 silicone.Notes reveal that catheter was placed (b)(6) 2024.Customer called the manufacturer to see if there was guidance in removing this catheter.Manufacturer recommended deflating the balloon 2 times and attempting to remove catheter.Alerted company that this was done and was recommended to contact the medical provider.Customer called to spaulding (releasing facility) to determine if there had been difficulties with the catheter.They stated that they had to place a 14 fr because the 16 fr would not place.Stated that they placed a silicone catheter because the standard catheter would not place.Customer stated that they would maintain current catheter.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿poor balloon design".However, there was insufficient information to confirm this potential root cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle." 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: 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: 19080238
• MDR Text Key: 340699970
• Report Number: 1018233-2024-01976
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2024
• 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: 03/22/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/12/2024; 05/08/2024
• Supplement Dates FDA Received: 04/25/2024; 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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