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

Model Number 165812

Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Device Fell (4014)

Patient Problems Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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 patient had a silicone urinary catheter (12fr) inserted on 6th september due to elevated urea and creatine.While returning from the radiology department on the next day the patient's catheter fell out while attempting to stand.It was reported that the catheter was not snagged or pulled, and the patient reported no pain or discomfort.On examination the balloon which holds the catheter in the neck of the bladder seemed to have been ruptured and they were unable to identify why this might have happened.It was also reported that there was no indication currently that any part of the balloon remains in the patient and no haematuria was noted although urine was cloudy at this time.Routine ct kub (computed tomography of kidneys, ureters and bladder) planned again relating to ongoing elevated u&e.May also need cystoscopy due to rupture.

Event Description

It was reported that the patient had a silicone urinary catheter (12 fr) inserted on (b)(6) due to elevated urea and creatine.While returning from the radiology department on the next day the patient's catheter fell out while attempting to stand.It was also reported that the catheter was not snagged or pulled, and the patient reported no pain or discomfort.On examination the balloon which holds the catheter in the neck of the bladder seemed to have been ruptured, and they were unable to identify why this might have happened.It was also reported that there was no indication currently that any part of the balloon remains in the patient and no hematuria was noted, although urine was cloudy.The routine ct kub (computed tomography of the kidneys, ureters and bladder) planned again relating to ongoing elevated u&e.The patient also needs cystoscopy due to rupture.Per additional information received via email from the ibc on 06oct2020, the patient has reported no pain or discomfort and there was no indication of any balloon parts were left in the patient following the catheter.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.Visual inspection noted one two-way silicone foley catheter was received.Visual evaluation noted the balloon had burst across the entire circumference of the balloon's surface.No missing pieces were noted.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure mode could be due to tooling damaged (core pins).The product used for the treatment purposes.The product had failed to meet the specifications, and was influenced by the reported failure.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: "caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician." sterile: unless package is opened or damaged.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities.3cc balloon: use 5ml sterile water.5cc balloon: use 10ml sterile water.30cc balloon: use 35ml sterile water.Do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." h11: section a through f - the information provided by bd 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 bd.

Event Description

It was reported that the patient had a silicone urinary catheter (12 fr) inserted on (b)(6)due to elevated urea and creatine.While returning from the radiology department on the next day the patient's catheter fell out while attempting to stand.It was also reported that the catheter was not snagged or pulled, and the patient reported no pain or discomfort.On examination the balloon which holds the catheter in the neck of the bladder seemed to have been ruptured, and they were unable to identify why this might have happened.It was also reported that there was no indication currently that any part of the balloon remains in the patient and no hematuria was noted, although urine was cloudy.The routine ct kub (computed tomography of the kidneys, ureters and bladder) planned again relating to ongoing elevated u&e.The patient also needs cystoscopy due to rupture.Per additional information received via email from the ibc on 06oct2020, the patient has reported no pain or discomfort and there was no indication of any balloon parts were left in the patient following the catheter.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.Visual inspection noted one two-way silicone foley catheter was received.Visual evaluation noted the balloon had burst across the entire circumference of the balloon's surface.No missing pieces were noted.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure mode could be due to tooling damaged (core pins).The product used for the treatment purposes.The product had failed to meet the specifications, and was influenced by the reported failure.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: "caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: unless package is opened or damaged.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities: 3cc balloon: use 5ml sterile water; 5cc balloon: use 10ml sterile water; 30cc balloon: use 35ml sterile water.Do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.".Correction: e4, this correction is being filed as the original supplemental had the incorrect year of "2020".This supplemental contains the correct year as "2021".H11:section a through f - the information provided by bd 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 bd.

• 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 GA 30014
• MDR Report Key: 10623118
• MDR Text Key: 210061490
• Report Number: 1018233-2020-06317
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029738
• UDI-Public: (01)00801741029738
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 165812
• Device Catalogue Number: 165812
• Device Lot Number: NGDZ0121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 01/13/2020; 01/13/2021
• Supplement Dates FDA Received: 02/02/2021; 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention