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

Catalog Number 319216AM

Device Problem Component Missing (2306)

Patient Problem Discomfort (2330)

Event Date 02/18/2024

Event Type  malfunction  

Event Description

It was reported that there were only 2 swabs out of three present in the surestep foley tray system kit.The patient experienced inconvenience.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "incorrect operation of unit packaging in box".The dhr review could not be performed without a lot number.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that there were only 2 swabs out of three present in the surestep foley tray system kit.The patient experienced inconvenience.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Type of Device: FOLEY TRAY
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18948573
• MDR Text Key: 338890253
• Report Number: 1018233-2024-01478
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319216AM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• 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