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

Device Problem Occlusion Within Device (1423)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.

Event Description

It was reported that the patient has sediment in her urine, which builds up within the silicone foley catheter and causes a blockage.Therefore, the catheters are reportedly replaced every three days.No patient injury reported; however, it was reported that the patient experienced pain.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the silicone catheter product ifus are found to be adequate based on past reviews.(b)(4).

Event Description

It was reported that the patient had sediment in her urine, which built up within the silicone foley catheter and caused a blockage.Therefore, the catheters were reportedly replaced every three days.No patient injury reported; however, it was reported that the patient allegedly experienced pain.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7321782
• MDR Text Key: 101966949
• Report Number: 1018233-2018-00725
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

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
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1