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

Catalog Number 806318

Device Problem Partial Blockage (1065)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  malfunction  

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 after placement of device of the foley catheter, the irrigation lumen clogged and the patient discontinued to use it.Another same event occurred.

Manufacturer Narrative

The reported event was confirmed as a manufacturing related.The device did not meet the specifications.The sample was evaluated and observed the improper punching of irrigation eye caused the water unable to flow out through it.The root cause for this failure mode was due to eye punch (eye slug not removed) caused no flow or low flow at the time of placement.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: "[contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) be careful that the catheter is not exposed to ointments, contrast medium or oil based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) patients with known allergy to silver coated catheter." the actual/suspected device was inspected.

Event Description

It was reported that after placement of the foley catheter the irrigation lumen was clogged and the patient discontinued to use it.Another same event was occurred.

• Brand Name: BARDIA ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11038463
• MDR Text Key: 222386188
• Report Number: 1018233-2020-21789
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

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: 806318
• Device Lot Number: 9NT117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other