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

Model Number 165816

Device Problems Physical Resistance (2578); Folded (2630); Mushroomed (2987)

Patient Problem Pain (1994)

Event Date 03/27/2018

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.

Event Description

It was reported that, around 5:45am on (b)(6) 2018, the nurse attached the syringe to the foley catheter balloon port, retreiving 10ml.The patient was laying supine during this time.As rn asked the patient to breathe, the foley was slowly pulled out.However, the patient begun screaming in pain as the catheter was being removed.The nurse felt slight resistance on the catheter, and stopped immediately.The charge nurse, (b)(6), was notified.Dr.(b)(6) was notified and was at bedside by 6:00am.Dr.(b)(6) removed foley catheter completely.Upon removal, below the catheter tip, where the balloon is located was a fold over the tubing; almost as if it had a mushroom cap in the middle of the foley catheter.The end of the catheter was saved and given to (b)(6), rn.The patient had no noticeable bleeding.

Manufacturer Narrative

The reported issue (it was reported that, around 5:45am on (b)(6)2018, the nurse "attached the syringe to the foley catheter balloon port, retreiving 10ml out.The patient was laying supine during this time.As rn asked the patient to breathe, the foley was slowly pulled out.However, the patient started screaming in pain when the catheter started to come out.At the same time, rn felt slight resistance on the catheter, and stopped immediately.Charge rn, mara, was notified.Dr.Schor was notified and was at bedside by 6:00am.Dr.Schor removed foley catheter completely.Upon removal, below the catheter tip, where the balloon is located was a fold over the tubing.Almost as if it had a mushroom cap in the middle of the foley catheter.The end of the catheter was saved and given to sarah metcalf, rn.The patient had no noticeable bleeding.") was unconfirmed, since the problem could not be reproduced.Per visual evaluation a cuff roll was not observed.During the functional evaluation a cuff roll was not formed.Dimensional evaluation the catheter was found within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿foley catheter removal: 1.To deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.2.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.3.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.4.If the balloon will not deflate and if permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.5.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." correction: additional information.

Event Description

It was reported that, around 5:45am on (b)(6)2018, the nurse attached the syringe to the foley catheter balloon port, retreiving 10ml.The patient was laying supine during this time.As rn asked the patient to breathe, the foley was slowly pulled out.However, the patient begun screaming in pain as the catheter was being removed.The nurse felt slight resistance on the catheter, and stopped immediately.The charge nurse, mara, was notified.Dr.Schor was notified and was at bedside by 6:00am.Dr.Schor removed foley catheter completely.Upon removal, below the catheter tip, where the balloon is located was a fold over the tubing; almost as if it had a mushroom cap in the middle of the foley catheter.The end of the catheter was saved and given to sarah metcalf, rn.The patient had no noticeable bleeding.

• Brand Name: BARDEX® ALL-SILICONE FOLEY 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: 7433975
• MDR Text Key: 105686652
• Report Number: 1018233-2018-01205
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGBY2763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Date Manufacturer Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 64