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

Model Number 0165SI14

Device Problem Deflation Problem (1149)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that on the 21st day after placement, the catheter balloon was difficult to deflate.The valve area was cut, but the water was not able to be removed.An additional intervention by urologist was scheduled to be performed.Per follow up with ibc via mail on (b)(6) 2020, the water was removed by inserting guidewire to inflation lumen and another device was placed to complete the procedure.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be manufacturing related due to operator error/ mechanical error/ thin rubberized layer.It was unknown whether the device had met relevant specifications.The product used for urological care.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "[contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental.Balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients: (1) patients who are or have been allergic to natural rubber latex.(2) patients with known allergy to silver coated catheter.[directions for use] 1.Method of use to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered." 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 Description

It was reported that on the 21st day after the placement, the catheter balloon difficult to deflate.The valve area was cut, but the water was unable to be remove.An additional intervention by the urologist was scheduled to be performed.Per follow-up with ibc via email on 27nov2020, the water was removed by inserting the guidewire to inflate the lumen and another device was placed to complete the procedure.

• Brand Name: BARDEX I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11000149
• MDR Text Key: 221236619
• Report Number: 1018233-2020-21653
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0165SI14
• Device Catalogue Number: 0165SI14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention