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

Catalog Number UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/16/2020

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 defective foley catheter failed during a case.As per the follow up information received via email on (b)(6) 2020, it was reported that, the foley catheter was inserted into patient¿s uterus for counter pressure.After couple of years, a piece of rubber was found in the uterus and it was alleged that it is the part of the catheter.

Event Description

It was reported that the defective foley catheter failed during a case.As per the follow up information received via email on (b)(6) 2020 it was reported that the foley catheter inserted into the patient uterus for counter pressure.After couple of years a piece of rubber was found in the uterus and alleged that it was the part of the catheter.

Manufacturer Narrative

The reported event was confirmed as a use related.The product used for urological care.The root cause of this failure mode was due to a user related - user did not use the device as intended.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.Correction: b, d, e.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.H3 other text : the device was not returned.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11222911
• MDR Text Key: 228434324
• Report Number: 1018233-2021-00088
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention