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

Catalog Number 129414M

Device Problem Decrease in Pressure (1490)

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

Event Date 02/01/2021

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 catheter fell out after the placement.There was no problem in the pretest before use.Postoperative spontaneous removal found.When distilled water was injected again, distilled water leakage was confirmed from the eye.Lumen to lumen suspected.

Manufacturer Narrative

The reported event was confirmed as a manufacturing related.Visual inspection noted that there was no visual defects on the returned sample.The sample was inflated with water and observed water leaking through the drainage eye.The catheter was dissected and observed a tear on the rubberize layer of the temperature sensing catheter (tsc) lumen.The tear was examined under microscope and noted to be rounded but not smooth and identified this was related to manufacturing.The reported failure was able to reproduced.The product had cause the reported failure.The failure was caused by the misuse of the product.The root cause for this failure mode was manufacturing related due to operator error or mechanical error or thin rubberized layer or poor stripping.A review of the manufacturing process indicates that the process was capable of producing this type of defect.Based on the sample returned it was confirmed as a manufacturing related issue.The device history record was reviewed and found a possible manufacturing issue that could have caused or contributed to the reported event.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 or 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 percent 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." 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 catheter fell out after the placement.It was noted that there was no problem in the pretest before the use.The postoperative spontaneous removal was found.When the distilled water was injected again the distilled water leakage was confirmed from the eye.The lumen to lumen leakage was suspected.

• Brand Name: BARDEX I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11379063
• MDR Text Key: 233530892
• Report Number: 1018233-2021-00812
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2023
• Device Catalogue Number: 129414M
• Device Lot Number: MYEU0770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 05/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other