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

Model Number 165818

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the catheter fell out of the patient in use.

Event Description

It was reported that the catheter fell out of the patient in use.

Manufacturer Narrative

The reported event was confirmed as cause unknown.Received 1 silicone catheter for evaluation.No visual defects were observed along the catheter.Per the functional evaluation, the balloon was inflated with 10cc of air using a syringe and it was deflated.After the balloon was inflated with 10 cc of a mix of tap water and blue methylene, using a syringe, the water came out due to a pinhole.The catheter's active length was measured and results were as follows: short side= 0.7415¿, long side=0.7620¿ (per specification the active length is 0.6¿ to 0.9¿).The catheter active length was found within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use" (b)(4).

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7148585
• MDR Text Key: 95928717
• Report Number: 1018233-2017-06497
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029769
• UDI-Public: (01)00801741029769
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

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: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 165818
• Device Catalogue Number: 165818
• Device Lot Number: NGBT1566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1