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

Catalog Number UNKNOWN

Device Problems Device Markings/Labelling Problem (2911); Illegible Information (4050)

Patient Problem 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 latex foleys had lack of labeling and also mentioned that it was a situational awareness and stated that they would like it to be more visible on the label for latex or latex free.

Event Description

It was reported that latex foleys had lack of labeling and also mentioned that it was a situational awareness and stated that they would like it to be more visible on the label for latex or latex free.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode could be "inadequate instructions / incorrect translation".A potential root cause for this failure could be "incorrect/ missing translation; missing instructions".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.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.

• Brand Name: FOLEY TRAYS
• Type of Device: UNKNOWN FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10347087
• MDR Text Key: 202370386
• Report Number: 1018233-2020-04876
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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: 07/06/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1