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

Model Number 119110

Device Problem Partial Blockage (1065)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

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 no urine flow was observed on the day of use due to catheter blockage.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.Visual inspection of the sample noted no obvious visible defects.The catheter drainage lumen was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and it was noted that the solution did not flow at all.The drainage lumen was cut to find extra silicone in the drainage lumen causing a complete blockage near the trifurcation.This does not meet the specification as "check for defects: excessive material (over fill), bubbles/voids, splits and/or blemishes.".A potential root cause for this failure could be ¿tooling misalignment¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that no urine flow was observed on the day of use due to catheter blockage.

• Brand Name: BARDEX ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING PEDIATRIC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11292249
• MDR Text Key: 230672990
• Report Number: 1018233-2021-00306
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046001
• UDI-Public: (01)00801741046001
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 119110
• Device Catalogue Number: 119110
• Device Lot Number: NGDT0371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Date Manufacturer Received: 06/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other