MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD FOLEY TRAY WITH BARDEX ALL SILICONE FOLEY CATHETER; SILICON FOLEY CATHETER

Model Number	897216
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the customer received 18fr foley tray instead of the 16fr tray.
Additional 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 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 or Problem Description
It was reported that the customer received 18fr foley tray instead of the 16fr tray.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as the alleged device is not sold by bd.H11:section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the customer received 18fr foley tray instead of the 16fr tray.

• Brand Name: BARD FOLEY TRAY WITH BARDEX ALL SILICONE FOLEY CATHETER
• Common Device Name: SILICON FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10727746
• Report Number: 1018233-2020-20380
• Device Sequence Number: 1720799
• Product Code: EZL
• UDI-Device Identifier: 00801741020322
• UDI-Public: (01)00801741020322
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: 897216
• Device Catalogue Number: 897216
• Device Lot Number: NGEN1771
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/27/2020; 01/06/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/09/2020; 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other