MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP FOLEY TRAY SYATEM

Model Number 175814

Device Problem Leak/Splash (1354)

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 the catheter was leaking at the disc next to the blue port.The first catheter was discarded, but one sample was kept.

Event Description

It was reported that the catheter was leaking at the disc next to the blue port.The first catheter was discarded, but one sample was kept.

Manufacturer Narrative

Upon further review, bard/bd has determined that this mdr was initially reported in error as this event is not reportable.Correction: brand name, common device name, manufacturer name, city and state, pma/510k.

• Brand Name: SURESTEP FOLEY TRAY SYATEM
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9290445
• MDR Text Key: 179431523
• Report Number: 1018233-2019-07121
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034152
• UDI-Public: (01)00801741034152
• Combination Product (y/n): N
• PMA/PMN Number: K070508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: 175814
• Device Catalogue Number: A942206
• Device Lot Number: NGCV1445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1