MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 2- WAY 75CC BARDEX LUBRICATH FOLEY CATHETER

Model Number	01237524
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 a lumen to lumen leak was found during sample evaluation.
Additional Manufacturer Narrative
The reported event was confirmed.A 75cc amber lubricath foley was returned open with its original packaging.A plastic connector was attached to the drainage funnel and the balloon appeared to be collapsed.A sodium chloride syringe was also returned.In the previous investigation, a 10cc leur lock syringe was used to attempt to inflate the catheter with 80cc of di water.Water was seen leaking from the catheter drainage eye which is indicative of lumen to lumen leak.This would fail the functional testing per inspection procedure.A potential root cause could be due to a "machine or operator error" during the water dip of the buildup dipping process.Another potential root cause could be due to operator error when removing catheters from the form during the stripping process.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not completed as this would not likely because by the user.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 a lumen to lumen leak was found during the sample evaluation.

• Brand Name: 2- WAY 75CC 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: 10014834
• Report Number: 1018233-2020-02948
• Device Sequence Number: 2813534
• Product Code: EZC
• UDI-Device Identifier: 00801741017742
• UDI-Public: (01)00801741017742
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 04/10/2024
• Device Model Number: 01237524
• Device Catalogue Number: 01237524
• Device Lot Number: NGDU2657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1