MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEXLUBRI-SIL I.C.ALL-SILICONE TEMP SENSING FOLEY CATHETER

Model Number 119314M

Device Problems Calcified (1077); Inaccurate Flow Rate (1249)

Patient Problems Patient Problem/Medical Problem (2688); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/08/2020

Event Type  Injury  

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 urine would partially drained from the foley catheter or would allegedly stop the drainage of urine from the foley catheter.This was a recurring issue.In the first scenario, 1 lasix iv was given and approximately 200cc urine was drained per hour.The registered nurse (rn) noted femoral central venous pressure (cvp) increased to 30.Despite of the drained urine, the bladder scan showed 1.1l of urine in the bladder.The foley catheter was changed and all urine was emptied from the bladder and then the control venous pressure came back to the normal range.In second scenario, there was no urine flow noted from the foley catheter and was unable to irrigate.The bladder scan showed 135ml of urine.The foley catheter was removed and urine drained.In both instances, there was sediment observed on the tip of foley catheter.Per follow up on 21oct2020, the sediment builds up on the end of the foley catheter did contribute to the blockage and urine flow issue.In a few instances, the complainant had some slow flow vs no flow to the durometer bag.However, the bladder scan revealed urine not fully emptying from the bladder.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "lumen wall thickness undersized / inadequate material selection".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: "[warnings] 1.Method for use (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients ·patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [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: patients with known allergy to silver coated catheter." 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.

Event Description

It was reported that the urine would partially drained from the foley catheter or would allegedly stop the drainage of urine from the foley catheter.This was a recurring issue.In the first scenario, 1 lasix iv was given and approximately 200cc urine was drained per hour.The registered nurse (rn) noted femoral central venous pressure (cvp) increased to 30.Despite of the drained urine, the bladder scan showed 1.1l of urine in the bladder.The foley catheter was changed and all urine was emptied from the bladder and then the control venous pressure came back to the normal range.In second scenario, there was no urine flow noted from the foley catheter and was unable to irrigate.The bladder scan showed 135ml of urine.The foley catheter was removed and urine drained.In both instances, there was sediment observed on the tip of foley catheter.Per follow up on 21oct2020, the sediment builds up on the end of the foley catheter did contribute to the blockage and urine flow issue.In a few instances, the complainant had some slow flow vs no flow to the durometer bag.However, the bladder scan revealed urine not fully emptying from the bladder.

• Brand Name: BARDEXLUBRI-SIL I.C.ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: TEMP SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10774688
• MDR Text Key: 214304964
• Report Number: 1018233-2020-20664
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039904
• UDI-Public: (01)00801741039904
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 119314M
• Device Catalogue Number: 119314M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention