MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL I. C. 2 WAY ALL-SILICONE FOLEY CATHETER WITH 5CC BALLOON; FOLEY CATHETER (SILICONE)

Catalog Number 1758SI14

Device Problems Deflation Problem (1149); Mushroomed (2987)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2017

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 there was difficulty deflating the balloon; however, the catheter was removed successfully.After two days of use; upon removal, a cuff was noted.Subsequently, the user attempted to inflate and deflate the balloon several times; however, the cuff remained.No patient injury was reported.

Manufacturer Narrative

Received 1 silicone catheter.The reported issue was confirmed during the preliminary evaluation.Per visual inspection, there appeared to be a ridge/cuff on the balloon.However, the functional evaluation was unable to reproduce the reported event due to sample condition after shipment to the manufacturing location.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: "caution: do not aspirate urine through drainage funnel wall.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Recommended inflation capacities: 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon:use 35cc sterile water do not exceed recommended capacities.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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.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." (b)(4).

Event Description

It was reported that there was difficulty deflating the balloon; however, the catheter was removed successfully.After two days of use; upon removal, a cuff was noted.Subsequently, the user attempted to inflate and deflate the balloon several times; however, the cuff remained.No patient injury was reported.

• Brand Name: BARDEX LUBRI-SIL I. C. 2 WAY ALL-SILICONE FOLEY CATHETER WITH 5CC BALLOON
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6639247
• MDR Text Key: 77614513
• Report Number: 1018233-2017-03121
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K984136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2021
• Device Catalogue Number: 1758SI14
• Device Lot Number: NGAQ1707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1