MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® FOLEY TRAY; COMPONENT (FOLEY TRAY)

Catalog Number 900016A

Device Problems Defective Component (2292); Component Missing (2306); Moisture or Humidity Problem (2986)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2019

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 there was no water inside the syringe.

Event Description

It was reported that there was no water inside the syringe.

Manufacturer Narrative

The reported event was confirmed as supplier related.The evaluation found that there was plastic debris from the plunger stuck or trapped in between the gasket and the inner wall of the barrel.It caused void/channel and water leaked out.There was a possibility that this defect was created during molding or the syringe manufacturing process at the supplier side.The sample was sent to the supplier.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)this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4)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.] (5)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)do not use in patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter.[shape, configuration and principles].Bard® i.C.Foley tray b consists of a balloon catheter, urine-collecting bag for closed drainage system, syringe prefilled with sterile water, water-soluble lubricant, antiseptic solution, waterproof sheet, tweezers, gauze pads, cotton balls, and vinyl gloves.There are two types of catheters, two way and three way, and several types of closed drainage bags.The catheter and/or bag included in the tray will depend on the product.".

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY TRAY
• Type of Device: COMPONENT (FOLEY TRAY)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8433540
• MDR Text Key: 139412542
• Report Number: 1018233-2019-01427
• Device Sequence Number: 0
• Product Code: MJC
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/03/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900016A
• Device Lot Number: MYCVBB65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Date Manufacturer Received: 04/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1