MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® COUDE FOLEY CATHETER

Model Number	A304918
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported by the facility that a patient with a known latex allergy was catheterized with a surestep tray because the nurse did not see a latex allergy warning label.It is unknown if the patient received medical intervention.The facility reported that the placement of the warning portion of the label was hidden on the package.It was suggested that the warning label be repeated on the larger portion of the label, using a color different from the other lettering.
Additional Manufacturer Narrative
Upon further review, bard/bd medical has determined that this mdr was initially reported in error as this event is not reportable.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 or Problem Description
It was reported by the facility that a patient with a known latex allergy was catheterized with a surestep tray because the nurse did not see a latex allergy warning label.No medical intervention was reported.The facility reported that the placement of the warning portion of the label was hidden on the package.It was suggested that the warning label be repeated on the larger portion of the label, using a color different from the other lettering.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® COUDE FOLEY CATHETER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9729381
• Report Number: 1018233-2020-01153
• Device Sequence Number: 2927518
• Product Code: EZC
• UDI-Device Identifier: 00801741100499
• UDI-Public: (01)00801741100499
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: A304918
• Device Catalogue Number: A304918
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 02/27/2020
• 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