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

Device Problems Leak/Splash (1354); Misassembled (1398); Component Missing (2306)

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 cap was missing from the lubricant gel causing the gel to spill inside of the tray.

Manufacturer Narrative

The reported event was confirmed, a root cause could not be determined.The photo sample showed a tray with some yellow-orange foreign substance inside.The substance resembled dried out lubricant.A potential root cause for this failure could be "incorrect operation." the lot number is unknown therefore the device history record could not be reviewed.The product family for this foley trays product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the foley trays product ifus are 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 cap was missing from the lubricant gel causing the gel to spill inside of the tray.

• Brand Name: FOLEY TRAYS
• Type of Device: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8669913
• MDR Text Key: 147070272
• Report Number: 1018233-2019-02926
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

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: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1