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

Model Number	175808
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2019
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 there was a foley issue reported at (b)(6) on (b)(6) 2019 by their 8d childrens floor.The 8 fr.Foley with lot # ngcz2377.The rn was met with resistance while inserting water into the balloon.Upon removal a pinhole was found in the balloon.There was no patient harm reported.Per follow up with the sales rep on 6feb2020, he confirmed that when he followed up in person he was made aware of this event on 24jan2020.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿notch not completely perforated¿.A potential root cause for this failure could be "inadequate pressure for punching machine".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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that there was a foley issue reported at (b)(6) on 08dec2019 by their 8d childrens floor.The 8 fr.Foley with lot # ngcz2377.The rn was met with resistance while inserting water into the balloon.Upon removal a pinhole was found in the balloon.There was no patient harm reported.Per follow up with the sales rep on 6feb2020, he confirmed that when he followed up in person he was made aware of this event on 24jan2020.

• Brand Name: BARDEX® PEDIATRIC ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9714146
• Report Number: 1018233-2020-01070
• Device Sequence Number: 3069544
• Product Code: EZL
• UDI-Device Identifier: 00801741034275
• UDI-Public: (01)00801741034275
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K984084
• 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): 03/31/2020

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: 10/31/2023
• Device Model Number: 175808
• Device Catalogue Number: 175808
• Device Lot Number: NGCZ2377
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 03/29/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1