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

Catalog Number UNKNOWN

Device Problems Expiration Date Error (2528); Device Markings/Labelling Problem (2911)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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 that the wipes were expired.

Event Description

It was reported that the wipes were expired.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be, "missing or incorrect labeling or instructions for use".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the foley tray product 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.H3 other text : the device was not returned.

• Brand Name: FOLEY TRAYS
• Type of Device: FOLEY TRAYS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10468665
• MDR Text Key: 209169990
• Report Number: 1018233-2020-05533
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1