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

Catalog Number 165814

Device Problem Deflation Problem (1149)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that it was difficult to deflate the balloon of the catheter.Reportedly, only 5ml of water was coming out causing trauma and bleeding to the patient.Five patients were admitted to hospital.It is unknown at this time if the patient required medical intervention.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿valve stem too long or too short and valve body or stem deformed¿ with a potential root cause of "poor interface/fit between inflation syringe and/ or inflation funnel and incorrect alignment of valve assembly".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: "visually inspect the product for any imperfections or surface deterioration prior to use use luer tip syringe to inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." section a through f - the information provided by bd 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 bd.

Event Description

It was reported that it was difficult to deflate the balloon of the catheter.Reportedly, only 5ml of water was coming out causing trauma and bleeding to the patient.Five patients were admitted to hospital.It is unknown at this time if the patient required medical intervention.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9871423
• MDR Text Key: 187086480
• Report Number: 1018233-2020-02045
• Device Sequence Number: 1
• Product Code: GBM
• Combination Product (y/n): N
• PMA/PMN Number: K760093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 165814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization