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

Model Number	0165L22
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Urinary Tract Infection (2120); No Code Available (3191)
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 that the patient had a latex allergy, and was using the silicone coated foley catheter.The patient noted that the silicone coating came off during use, and believed she developed an infection and had a pungent smell as a result.No medical intervention was reported, however, the patient noted that she had a topical cream that she had been using.
Additional Manufacturer Narrative
The reported event was confirmed based on the ifu, event, and reported product.No sample was returned.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿the ifu, states "caution: this product contains natural rubber latex which may cause allergic reactions." 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 that the patient had a latex allergy, and was using the silicone coated foley catheter.The patient noted that the silicone coating came off during use, and believed she developed an infection and had a pungent smell as a result.No medical intervention was reported, however, the patient noted that she had a topical cream that she had been using.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: LUBRICATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9526184
• Report Number: 1018233-2019-08276
• Device Sequence Number: 14128936
• Product Code: EZC
• UDI-Device Identifier: 00801741017513
• UDI-Public: (01)00801741017513
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/18/2020

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: 0165L22
• Device Catalogue Number: 0165L22
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/18/2020
• 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