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

Catalog Number 165812

Device Problem Dent in Material (2526)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/18/2023

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 the water could not be removed from the foley catheter during use.Unfortunately, the urinary catheter had to be removed with water remaining in the balloon and the patient experienced some minor trauma.On investigating the removed catheter, they were able to confirm that it was faulty.It appeared very deformed with it just bulging out from one side of the catheter.They were able to inject water into the balloon and remove that water that they had injected but could not deflate it below a certain volume.When they checked another catheter from the same batch, they were able to inflate and deflate the balloon without problem.However, the balloon was very lop-sided.

Manufacturer Narrative

The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.Visual evaluation of the returned photo sample noted one opened (without original packaging), two-way silicone foley.Visual inspection of the photo sample noted the catheter balloon was inflate and the balloon concentricity was observed to be 100:00.A potential root cause for this failure mode could be, ¿shaft strength (materials of shaft is too soft and torsion occurs - not enough support)¿.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: "intended use: for urological use only.Indications: bard® all-silicone foley.Catheters are indicated for any clinical condition requiring drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.Contraindication: no known.Contraindications.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Do not use device if package is opened or damaged.Do not aspirate urine through drainage funnel wall.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness, or death of the patient.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Warnings: on catheter, do not use ointments or lubricants having a petrolatum base.It may cause balloon to burst".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.

Event Description

It was reported that the water could not be removed from the foley catheter during use.Unfortunately, the urinary catheter had to be removed with water remaining in the balloon and the patient experienced some minor trauma.On investigating the removed catheter, they were able to confirm that it was faulty.It appeared very deformed with it just bulging out from one side of the catheter.They were able to inject water into the balloon and remove that water that they had injected but could not deflate it below a certain volume.When they checked another catheter from the same batch, they were able to inflate and deflate the balloon without problem.However, the balloon was very lop-sided.

Manufacturer Narrative

The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.Visual evaluation of the returned photo sample noted one opened (without original packaging), two-way silicone foley.Visual inspection of the photo sample noted the catheter balloon was inflate and the balloon concentricity was observed to be 100:00.As compared to attachment.This does not meet the specification "balloon symmetry shall not exceed a ratio of 70:30 when measured form the side of the shaft." 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 release of balloon during oven drying curing¿.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: "intended use: for urological use only.Indications: bard® all-silicone foley catheters are indicated for any clinical condition requiring drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.Contraindication: no known contraindications caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Do not use device if package is opened or damaged.Do not aspirate urine through drainage funnel wall.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness, or death of the patient.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Warnings: on catheter, do not use ointments or lubricants having a petrolatum base.It may cause balloon to burst" correction: d,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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the water could not be removed from the foley catheter during use.Unfortunately, the urinary catheter had to be removed with water remaining in the balloon and the patient experienced some minor trauma.On investigating the removed catheter, they were able to confirm that it was faulty.It appeared very deformed with it just bulging out from one side of the catheter.They were able to inject water into the balloon and remove that water that they had injected but could not deflate it below a certain volume.When they checked another catheter from the same batch, they were able to inflate and deflate the balloon without problem.However, the balloon was very lop-sided.

• Brand Name: BARDEX® ALL-SILICONE 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: 18436146
• MDR Text Key: 331911781
• Report Number: 1018233-2023-09437
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029738
• UDI-Public: (01)00801741029738
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

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
• Device Catalogue Number: 165812
• Device Lot Number: MYHN1895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 04/08/2024; 04/23/2024
• Supplement Dates FDA Received: 04/10/2024; 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• 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