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

Model Number	0170SI16
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/29/2022
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 patient said this was not the correct catheter and these silicone coude foley catheters did not work, and they were hard for the patient to use.Patient¿s doctor had to use a wire to insert the catheters in place.The catheter that patient needed were on back order.
Event or Problem Description
It was reported that patient said this was not the correct catheter and these silicone coude foley catheters did not work, and they were hard for the patient to use.Patient¿s doctor had to use a wire to insert the catheters in place.The catheter that patient needed were on back order.
Additional Manufacturer Narrative
The reported event is unconfirmed as the product meets specifications.Visual evaluation noted received a 2-way all silicone catheter in unopened packaging with no obvious defects present.Inflated balloon with 10 ml of solution and the catheter rested with no leaks.Deflated balloon passively with no cuffing or leaks noted.Therefore, product meets specifications which states "missing/incorrect components are not allowed." the product was used for patient diagnostic or treatment.The product was not influenced by the reported event.A dhr review is not required as the reported event is unconfirmed.A labelling review is not required as the reported event is unconfirmed.H11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15988542
• Report Number: 1018233-2022-09559
• Device Sequence Number: 5922892
• Product Code: EZL
• UDI-Device Identifier: 00801741025341
• UDI-Public: (01)00801741025341
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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 Model Number: 0170SI16
• Device Catalogue Number: 0170SI16
• Device Lot Number: NGGT3407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown