MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER; 8FR SILICONE CATHETER

Model Number 119108

Device Problems Inaccurate Flow Rate (1249); Obstruction of Flow (2423)

Patient Problem No Patient Involvement (2645)

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 an 8 fr temperature sensing foley catheter would not drain.This was noted prior to use during a pretest.No medical intervention was reported.Catheter 119108 is part of tray/kit 849408.

Event Description

It was reported that an 8 fr temperature sensing foley catheter would not drain.This was noted prior to use during a pretest.No medical intervention was reported.

Manufacturer Narrative

The reported event was unconfirmed.Visual inspection noted one meter bag with the silicone temperature sensing catheter and sample port connector was received.The tamper evidence seal was removed and not returned with the sample.Visual evaluation noted no obvious defects.The catheter's balloon was inflated with 3.5 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).The balloon rested for 30 minutes without leaks and passively deflated without issue, returning 3.5 ml of solution.No cuffing was noted during the deflation of the balloon.Balloon concentricity was observed to be 60:40.Filled drainage lumen with methylene blue and water solution and the solution was able to drain out of the eyelets and funnel.Active length of the catheter balloon was measured (0.4880") and found to be within specification (0.40" ± 0.10").The catheter measured to be 8fr.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: ¿1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.(fig.2) 3.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80 - 100 degree angle).Press the syringe firmly and twist gently to access the sampling port.(fig.3) 4.Slowly aspirate urine sample into syringe and remove syringe from sample port.(fig.4) 5.Unkink tubing and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab." h11: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.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: 8FR SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8846784
• MDR Text Key: 194927667
• Report Number: 1018233-2019-04378
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045998
• UDI-Public: (01)00801741045998
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGCY0860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1