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

Model Number	365716
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/01/2021
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.
Event or Problem Description
It was reported that the patient experienced allergic reactions with the use of latex urinary catheters.It was stated that the patient required surgical airway due to allergic reactions.The customer reported that upon reviewing their current materials, it was apparent that the labelling of foley kits and the individual catheters, with respect to latex-status had not been as effective as they wished.It was stated that the latex caution label was not easily visible, and it could be difficult to tell the difference between latex and latex-free kits.Also stated that the individual urinary catheters might also contain latex.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be due to " poor printer quality (equipment, toner) ".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿intended for use in the drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter throughout the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.Caution: this product contains natural rubber latex which may cause allergic reactions.Warning: do not use if allergic to iodine.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.¿ 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.
Event or Problem Description
It was reported that the patient experienced allergic reactions with the use of latex urinary catheters.It was stated that the patient required surgical airway due to allergic reactions.The customer reported that upon reviewing their current materials, it was apparent that the labelling of foley kits and the individual catheters, with respect to latex-status had not been as effective as they wished.It was stated that the latex caution label was not easily visible, and it could be difficult to tell the difference between latex and latex-free kits.Also stated that the individual urinary catheters might also contain latex.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY
• Common Device Name: 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13004348
• Report Number: 1018233-2021-08049
• Device Sequence Number: 17222522
• Product Code: EZC
• UDI-Device Identifier: 00801741077746
• UDI-Public: (01)00801741077746
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: Health Professional
• Device Model Number: 365716
• Device Catalogue Number: A800365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown