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

Catalog Number UNKNOWN

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Urinary Tract Infection (2120)

Event Date 01/26/2021

Event Type  Injury  

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 the catheter was too big for the patient and also stated that the doctor advised the patient to use different size catheter otherwise the patient will continue getting uti's.It was unknown what medical intervention was provided for urinary tract infections.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to operator error or user related (incorrect catheter size used or insufficient lubricant applied).The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The labeling review was unable to review due to the unknown product code.Although the product family was unknown the (foley catheter) ifus were found to be adequate based on past reviews.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.

Event Description

It was reported that the catheter was too big for the patient and also stated that the doctor advised the patient to use a different size catheter otherwise the patient will continue getting the urinary tract infections.It is unknown what medical intervention was provided for the urinary tract infection.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN LATEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11349146
• MDR Text Key: 232567984
• Report Number: 1018233-2021-00662
• 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): Y
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other