MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX 2-WAY 3CC ALL-SILICONE PEDIATRIC FOLEY CATHETER.

Model Number 165808

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Information (3190)

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 an 8 french foley catheter began leaking immediately after insertion due to a hole in the inflation lumen.

Manufacturer Narrative

Received 1 silicone catheter.The reported event was confirmed as manufacturing related.During the visual inspection, it was noted that there was a cut below the bifurcation area on the drainage lumen.Per the functional evaluation, the balloon was inflated with 5 ml of a mix of tap water and blue methylene using a syringe and no leakage on catheter balloon was found.Water was then injected by the drainage lumen and leakage was noted at 0.25¿ from the bifurcation area.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).

Event Description

It was reported that an 8 french foley catheter began leaking immediately after insertion due to a hole in the inflation lumen.Upon sample receipt, it was found that there was a tear on the drainage lumen of the catheter shaft.

• Brand Name: BARDEX 2-WAY 3CC ALL-SILICONE PEDIATRIC FOLEY CATHETER.
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6857675
• MDR Text Key: 85990488
• Report Number: 1018233-2017-04728
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029714
• UDI-Public: (01)00801741029714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

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: 02/28/2022
• Device Model Number: 165808
• Device Catalogue Number: 165808
• Device Lot Number: NGBP4171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1