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

Model Number 175818

Device Problems Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problem Pain (1994)

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 the balloon "bunched up" resulting in an extra ribbing around the foley catheter.The complainant reportedly tested the balloon by pulling back the syringe to remove the water from the balloon.The complainant experienced pain with removal of the catheter.

Event Description

It was reported that the balloon "bunched up" resulting in an extra ribbing around the foley catheter.The complainant reportedly tested the balloon by pulling back the syringe to remove the water from the balloon.The complainant experienced pain with removal of the catheter.

Manufacturer Narrative

The reported event was confirmed to be user related, based on improper use of the device.The visual evaluation of the returned sample noted one opened (no original packaging present), used catheter with some ribbing on the catheter balloon.No labeling was returned.The catheter balloon was inflated with 10ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) and the balloon concentricity was observed to be 60:40.The balloon was allowed to rest for 30 min with no leaks and passively deflated all 10 ml with no cuffing.The active length of the catheter balloon was measured (0.7255") and found to be within specification (0.6"-0.9").The catheter was confirmed to be 18 fr.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: "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.Note: aggressive traction, particularly in the presence of suturing, is not recommended for silicone foley catheters.Bard, bardex and lubri-sil are registered trademarks of c.R.Bard, inc.Or an affiliate.U.S.Patent number 5,179,174 and patent pending.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.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." corrections: lot#, concomitant medical products.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7890358
• MDR Text Key: 120903781
• Report Number: 1018233-2018-04262
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034176
• UDI-Public: (01)00801741034176
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/25/2021
• Device Model Number: 175818
• Device Catalogue Number: 175818
• Device Lot Number: NGAX2654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1