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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.It is 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.Potential root cause for this failure mode could be user related (example: contact with sharp object)/ exposure to petrolatum based products mechanical failure/operator error).The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.

Event Description

It was reported that the customer had a damaged catheter balloon.Customer stated that the shipment box was also damaged.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN LATEX CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12147806
• MDR Text Key: 260952419
• Report Number: 1018233-2021-04144
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other