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 Inflation Problem (1310); Misassembled (1398)

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

Event Date 10/16/2019

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 when the catheter was inserted into the patient it was difficult to inflate the balloon.It was also reported that when the user removed the catheter and tried to inflate the balloon again, the balloon was able to inflate.However, the water could not be removed.Per additional information received via email on (b)(6) 2019 from ibc representative, the second event occurred outside the patient.

Manufacturer Narrative

The reported event was confirmed as a manufacturing related issue.Visual evaluation of the returned sample noted one opened (without original packaging), silicone foley catheter with connected sample port connector (intact tamper evident seal) and inlet tube portion, in addition to a water syringe.Visual inspection of the sample noted the balloon was partially inflated.2cc of the remaining solution was removed and the balloon was deflated with difficulty.The catheter balloon was attempted to be inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).Resistance was observed and inflation was very difficult.The balloon was again deflated (with difficulty) and subsequently dissected to find the inflation notch not fully perforated (only a small slit was present).This is out of specification per inspection procedure which states, "inflation lumen notch not to penetrate drainage lumen and must be properly formed" although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿inadequate pressure on the machine to punch.¿ 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 (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 injuryed.] 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% povidine-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, 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.] (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.] directions for use: 1) clean the area around the external urethral meatus with the packaged cotton balls immersed in the antiseptics.2) lubricate the catheter shaft with the lubricant jelly.3) 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.4) pull the catheter slightly to seat the balloon at the level of the bladder neck.5) 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.".

Event Description

It was reported that when the catheter was inserted into the patient it was difficult to inflate the balloon.It was also reported that when the user removed the catheter and tried to inflate the balloon again, the balloon was able to inflate.However, the water could not be removed.Per additional information received via email on 30 october 2019 from ibc representative, the second event occurred outside the patient.

• 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
• MDR Report Key: 9320915
• MDR Text Key: 174858034
• Report Number: 1018233-2019-07307
• Device Sequence Number: 1
• Product Code: EZL
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGCV3436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1