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

Model Number 1758SI16

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that water leaked from the balloon on the foley catheter, which caused it to be deflated.

Manufacturer Narrative

The reported event was unconfirmed, since the reported failure could not be reproduced.The device did not fail to meet specifications.The product was used for treatment purposes.The product was not related to the reported failure.Visual evaluation of the returned sample noted five opened (without original packaging), silicone foley catheters.Visual inspection of the samples noted no obvious visible defects.The catheter balloons were inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) each.Balloon concentricity was observed to be 60:40 for four of the balloons, and 50:50 for one balloon.The balloons rested for 30 minutes without leaks and passively deflated without issue, returning 10ml of solution each.No cuffing was noted for any returned sample.Active length of the catheter balloons were measured (0.864 inches, 0.7380 inches, 0.7810 inches, 0.7460 inches, and 0.6430 inches) and found to be within specification.The catheters were all confirmed to be size 16 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: ¿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 are mat be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.".

Event Description

It was reported that water leaked from the balloon on the foley catheter, which caused it to be deflated.

• Brand Name: BARDEX® LUBRI-SIL® I.C. 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: 9315893
• MDR Text Key: 177835710
• Report Number: 1018233-2019-07279
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025228
• UDI-Public: (01)00801741025228
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1758SI16
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGCV0144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1