MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP FOLEY TRAY SYSTEM WITH BARD LUBRI-SIL TEMP SENSING FOLEY; SURESTEP FOLEY KIT (SYRINGE)

Model Number A119216M

Device Problems Short Fill (1575); 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 irrigation syringe had no water in it.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect operation".The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review was not performed because labeling could not have prevented the reported failure.Corrections: d10, h3.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.

Event Description

It was reported that the irrigation syringe had no water in it.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM WITH BARD LUBRI-SIL TEMP SENSING FOLEY
• Type of Device: SURESTEP FOLEY KIT (SYRINGE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10437976
• MDR Text Key: 204700556
• Report Number: 1018233-2020-05361
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741073687
• UDI-Public: (01)00801741073687
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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 Model Number: A119216M
• Device Catalogue Number: A119216M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1