MAUDE Adverse Event Report: BARD SDN. BHD. -8040607 BARDEX® I.C. FOLEY CATHETER; FOLEY CATHETER (LATEX)

Catalog Number 0165SI14

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2017

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 water flowed into the urine drainage bag when the user injected water into the catheter for pretest.The catheter was replaced.

Manufacturer Narrative

Upon further review, bard medical has determined that this mdr was initially reported in error on a 3500a form.The reported event was found to be exempt from reporting, per exemption e1997009.

Event Description

It was reported that water flowed into the urine drainage bag when the user injected water into the catheter for pretest.The catheter was replaced.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer (Section G): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6742807
• MDR Text Key: 81120552
• Report Number: 1018233-2017-03940
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165SI14
• Device Lot Number: MYBPBB11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• 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