MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

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 by customer that urine backs up into the catheter and causes it to pop off.

Event Description

It was reported that urine backs up into the male external catheter and caused it to pop off.Customer used bard drain bags and also advised with troubleshooting tips for vapor locked drainage bags.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure mode could be operator¿s error- missed plug the catheters into the spigot on the manifold and cause occluded drainage eye (reduced flow rate).The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the (latex foley catheter) product ifus were found to be adequate based on past reviews.H11: section a through f - the information provided by bd represents all 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: LATEX FOLEY CATHETER
• Type of Device: LATEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12050097
• MDR Text Key: 257827067
• Report Number: 1018233-2021-03729
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other