MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD LUBRICATH FOLEY CATHETER; FOLEY (902716)

Model Number	902716
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 balloon wouldn¿t inflate sterile water trapped in distal end and wouldn¿t draw it back and needed to cut to remove in case some fluid was inside proximal balloon.
Event or Problem Description
It was reported that the balloon wouldn¿t inflate sterile water trapped in distal end and wouldn¿t draw it back and needed to cut to remove in case some fluid was inside proximal balloon.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.Evaluation found that the catheter has bee cut into multiple pieces.Water can be introduced into the inflation lumen of all pieces using needle syringe without any obstruction.However, further investigation could not be performed on the returned catheter due to poor condition of the sample.Potential root cause for this failure mode could be pinch lumen/collapse lumen/thick sac thickness/valve damage/short inflation lumen.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: "inflate catheter balloon using sterile water and fill with recommended volume as referenced on product label." 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.

• Brand Name: BARD LUBRICATH FOLEY CATHETER
• Common Device Name: FOLEY (902716)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10408082
• Report Number: 1018233-2020-05211
• Device Sequence Number: 19557907
• Product Code: EZC
• UDI-Device Identifier: 00801741040467
• UDI-Public: (01)00801741040467(17)210930
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/14/2021

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: 11/28/2023
• Device Model Number: 902716
• Device Catalogue Number: 365716
• Device Lot Number: NGDT1561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1