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

Model Number 165816

Device Problems Break (1069); Burst Container or Vessel (1074); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 the silicone foley fell out of the patient 2 days after insertion at which time the nursing staff realized the balloon had popped.The foley was replaced with no patient impact.All pieces were accounted for.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause for this failure mode could be user related (example: contact with sharp object)/ / exposure to petrolatum based products mechanical failure/operator error.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: ¿caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile unless package is opened or damaged.Do not use if package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities: 3cc balloon: use 5cc sterile water; 5cc balloon: use 10cc sterile water; 15cc balloon: use 20cc sterile water; 20cc balloon: use 25cc sterile water; 30cc balloon: use 35cc sterile water; 40cc balloon: use 45cc sterile water; 75cc balloon: use 80cc sterile water.Do not exceed recommended capacities note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Bard is a registered trademark of c.R.Bard, inc.Or an affiliate.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact an adequately trained professional for assistance, as directed by hospital protocol.".

Event Description

It was reported that the silicone foley fell out of the patient 2 days after insertion at which time the nursing staff realized the balloon had popped.The foley was replaced with no patient impact.All pieces were accounted for.

Event Description

It was reported that the silicone foley fell out of the patient 2 days after insertion at which time the nursing staff realized the balloon had popped.The foley was replaced with no patient impact.All pieces were accounted for.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: LUBRICATH CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8870508
• MDR Text Key: 153820840
• Report Number: 1018233-2019-04558
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 165816
• Device Catalogue Number: 0165L16
• Device Lot Number: NGDR4168
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 08/08/2019; 09/22/2019
• Supplement Dates FDA Received: 08/14/2019; 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1