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

Device Problems Decrease in Pressure (1490); Material Puncture/Hole (1504)

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

Event Date 12/13/2022

Event Type  malfunction  

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 silicone catheter balloon was deflated in about 3-4 days, when initially placed the whole 10ml of fluid was inserted into the catheter for inflation.Representative responded that this issue sometimes happened with foley catheters particularly with balloons.This was not due to the dwell time, but rather due to osmosis.Osmosis was defined as the passage of water from a region of high concentration through a semi-permeable membrane to a region of lower concentration.The rate of fluid movement was dependent on the concentration of the fluid on the other side.In other words, if a patient had a high urine specific gravity (meaning more concentrated), then fluid will move out of the balloon faster.If the patient¿s urine was diluted (low specific gravity), osmosis would be at a slower rate.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "water lost via permeations".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number is unknown; therefore, the device history record could not be reviewed.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 bard 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 bard.H3 other text : the device was not returned.

Event Description

It was reported that the silicone catheter balloon was deflated in about 3-4 days, when initially placed the whole 10ml of fluid was inserted into the catheter for inflation.Representative responded that this issue sometimes happened with foley catheters particularly with balloons.This was not due to the dwell time, but rather due to osmosis.Osmosis was defined as the passage of water from a region of high concentration through a semi-permeable membrane to a region of lower concentration.The rate of fluid movement was dependent on the concentration of the fluid on the other side.In other words, if a patient had a high urine specific gravity (meaning more concentrated), then fluid will move out of the balloon faster.If the patient¿s urine was diluted (low specific gravity), osmosis would be at a slower rate.

• 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: 16077563
• MDR Text Key: 308469736
• Report Number: 1018233-2022-10023
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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