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

Model Number 175808

Device Problems Break (1069); Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Inflammation (1932)

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.The device was not returned.

Event Description

It was reported that the catheter had a pinhole at the joint between the catheter and the hub, as a result the catheter leaked.Allegedly, the patient experienced inflammation to the labial region.No medical intervention was reported.

Event Description

It was reported that the catheter had a pinhole at the joint between the catheter and the hub, as a result the catheter leaked.Allegedly, the patient experienced inflammation to the labial region.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.Visual evaluation of the returned sample noted one opened (no original packaging present), used silicone catheter present.Visual inspection of the catheter surface noted a small hole estimated to be 0.024" in diameter approximately 0.0290" from the junction where the shaft meets the bifurcation.The catheter balloon was inflated with 10ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) and no leaks were observed along the inflation lumen.The catheter drainage funnel was then flushed with a methylene blue solution and the solution immediately began to stream from the hole in the shaft.The active length of the catheter balloon was measured (0.4005") and found to be within specification (0.40" +/- 0.1").The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use was found adequate and states the following: ¿lubri-sil® all-silicone foley catheter warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile unless package is opened or damaged.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip tip syringe.Do not use needle.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.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.".

• 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: 7763571
• MDR Text Key: 117017869
• Report Number: 1018233-2018-03479
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034275
• UDI-Public: (01)00801741034275
• Combination Product (y/n): N
• PMA/PMN Number: K984084
• 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: 11/14/2018

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: Health Professional
• Device Expiration Date: 08/03/2022
• Device Model Number: 175808
• Device Catalogue Number: 175808
• Device Lot Number: NGBU2291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR