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

Model Number 175816

Device Problem Decrease in Pressure (1490)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the foley catheter was placed and fell out of the patient with the balloon intact.Per follow up via email 02/12/2021.No medical intervention was reported.

Manufacturer Narrative

The reported event was unconfirmed as the problem could not be reproduced.Visual inspection noted one two way silicone foley catheter was received with the meter bag inlet tubing, and the sample port connector.Visual evaluation noted no obvious defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1 percent aqueous methylene blue per 100 ml distilled water) and the balloon concentricity was observed to be 60 versus 40.The balloon rested for 30 minutes without leakage and passively deflated without issue or cuffing returning 10 ml of solution.The product was used for treatment purposes.It was determined that the product had no relationship with the event due to the investigation being unconfirmed through the sample evaluation.The product had met specifications.A potential root cause for this failure mode was unable to determine due to the reported event was unconfirmed.The investigation indicated that the reported issue was not manufacturing or supplier related.Therefore a device history record review was not required.Per investigation a labeling review was not required.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 actual/suspected device was inspected.

Event Description

It was reported that the foley catheter was placed and fell out of the patient with the balloon intact.Per follow up information received via email on 12feb2021 no medical intervention was reported.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11338143
• MDR Text Key: 232221486
• Report Number: 1018233-2021-00581
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGEX2089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 07/16/2021
• Supplement Dates FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other