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

Model Number	0196L18
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
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 catheter fell out of the patient the next day after placement.Per additional information received via email on (b)(6) 2019 from ibc representative, there was no damaged to the catheter.Per sample evaluation, the balloon was found to be asymmetric.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.When the returned lubricath red rubber catheter sample was inflated with 10cc in order to check for asymmetry, there were small droplets and water sprayed from the catheter during inflation, but it was not enough to affect the initial balloon size.The balloon was found to be asymmetric, failing specification as the balloon symmetry was 70/30 and the acceptable symmetry is 60/40.The root case of this failure is operator error in not applying the sac straight during the saccing process, resulting in a poor shape and asymmetry.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." 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 catheter fell out of the patient the next day after placement.Per additional information received via email on 18 september 2019 from ibc representative, there was no damaged to the catheter.Per sample evaluation, the balloon was found to be asymmetric.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUNCILL MODEL
• Common Device Name: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9202062
• Report Number: 1018233-2019-06556
• Device Sequence Number: 14076330
• Product Code: EZC
• UDI-Device Identifier: 00801741017933
• UDI-Public: (01)00801741017933
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: 0196L18
• Device Catalogue Number: 0196L18
• Device Lot Number: MCAT4983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 09/28/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1