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

Model Number 0165SI14

Device Problems Degraded (1153); Peeled/Delaminated (1454)

Patient Problem Burning Sensation (2146)

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 the patient experienced a burning sensation while using the foley catheter.Upon removal nursing staff determined that the balloon appeared to be degrading.Reportedly, the balloon looked to be peeling and dry rotted.

Event Description

It was reported that the patient experienced a burning sensation while using the foley catheter.Upon removal nursing staff determined that the balloon appeared to be degrading.Reportedly, the balloon looked to be peeling and dry rotted.

Manufacturer Narrative

The reported event was inconclusive due to poor sample condition.The inspector received one used, cut portion of a silicone catheter with the funnel end missing with no packaging.A ridge was noted on the balloon surface with a foreign material covering the inside and outside surfaces.The foreign material also covered the catheter tip.The catheter degradation was unable to be confirmed due to the excess amounts of foreign material on the product.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and /or lead to injury, illness or death of the patient.Valve type: use luer slip tip syringe.Do not use needle.Do not exceed recommended capacities as stated on the inflation lumen of the catheter.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: do not aspirate urine through drainage funnel.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Do not use if package is damaged.Recommended indwelling time not to exceed 28 days.".

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY TRAY SYSTEM - CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8452549
• MDR Text Key: 140173470
• Report Number: 1018233-2019-01538
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0165SI14
• Device Catalogue Number: 0165SI14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1