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

Model Number	806316
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120)
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.
Event or Problem Description
It was reported that the patient experienced pain upon insertion as the catheter was ribbed.The patient possibly developing urinary tract infection.No medical intervention reported.
Event or Problem Description
It was reported that the patient experienced pain upon insertion as the catheter was ribbed.The patient possibly developing urinary tract infection.No medical intervention reported.It was later reported from the customer contact via phone on 05jun2020, the balloon on the foley catheters were ribbed, so they caused pain during insertion and removal.The customer noted that she developed a urinary tract infection as a result of using these catheters and was prescribed antibiotics.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 experienced pain upon insertion as the catheter was ribbed.The patient possibly developing urinary tract infection.No medical intervention reported.It was later reported from the customer contact via phone on (b)(6)2020 , the balloon on the foley catheters were ribbed, so they caused pain during insertion and removal.The customer noted that the patient developed a urinary tract infection as a result of using these catheters and was prescribed antibiotics.
Additional Manufacturer Narrative
The reported event could not be confirmed.No sample was returned for evaluation.A potential root cause for this failure could be, "inadequate sterilization.¿ 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.

• Brand Name: BARDIA 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: 10122746
• Report Number: 1018233-2020-03631
• Device Sequence Number: 1800640
• Product Code: EZL
• UDI-Device Identifier: 00801741039119
• UDI-Public: (01)00801741039119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2020

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 Expiration Date: 03/31/2024
• Device Model Number: 806316
• Device Catalogue Number: 806316
• Device Lot Number: NGDS0571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/05/2020; 07/21/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 06/26/2020; 08/13/2020
• 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: Required Intervention