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

Catalog Number 1758SI16

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2019

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 water leakage occurred due to the balloon burst on the 7th day of use.

Event Description

It was reported that water leakage occurred due to the balloon burst on the 7th day of use.

Manufacturer Narrative

The reported event was confirmed, however, the cause is unknown.Visual evaluation of the returned sample noted one opened (without original packaging), silicone foley catheter with cut portion of inlet tubing.Visual inspection of the sample noted no that the catheter balloon had burst (with a tear measuring 0.5190 inches).This is out of specification per inspection procedure which states, "balloon must not be torn." no missing pieces were noted from the balloon.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿tooling damaged (core pins).¿ the device history record was reviewed and found nothing 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 do not inflate the balloon in the urethra.[the urethra may be injured.] 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: do not reuse do not resterilize this device contains 10% povidine-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.Be careful that the catheter is not exposed to ointments, contract 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.] 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.] directions for use: clean the area around the external urethral meatus with the packaged cotton balls immersed in the antiseptics.Lubricate the catheter shaft with the lubricant jelly.Carefully insert the catheter into the urethral meatus.After the balloon advanced in the bladder, attach the needleless syringe, and gently infuse the specified volume of sterile water to inflate the balloon.Pull the catheter slightly to seat the balloon at the level of the bladder neck.To deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal 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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9527384
• MDR Text Key: 177945673
• Report Number: 1018233-2019-08298
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGCY1924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1