MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY; COMPONENT

Catalog Number 319214A

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 01/17/2020

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 user found a sterilization pouch opened and not sealed when the cardboard box was opened.

Manufacturer Narrative

The reported event was confirmed, however, the cause is unknown.Evaluation found that the bottom part of the package was opened.The exact cause of how and when the problem occurred could not be determined.The potential root cause for this failure could be user related / rough handling/ improper storage of the product.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[storage method and expiration date] 1.Storage store in a dry, cool place away from heat, moisture, and direct sunlight.2.Expiration date indicated on the direct package and the outer box." 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 user found a sterilization pouch opened and not sealed when the cardboard box was opened.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Type of Device: COMPONENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9672054
• MDR Text Key: 183976914
• Report Number: 1018233-2020-00759
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: 319214A
• Device Lot Number: MYDS5506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1