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

Model Number 165816

Device Problems Material Invagination (1336); Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

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 there was an issue with the foley catheter upon removal.The complainant reported that it took 9 attempts to remove the catheter and when they finally removed it, there was bleeding noted.The catheter was reportedly observed to have 'rolled' on itself in the balloon area upon removal.The complainant noted that the associates cut the tip off the catheter to be able to share what was experienced.No medical intervention was reported.The associates reportedly used another catheter to help troubleshoot, and experienced the same issue with the rolling.

Manufacturer Narrative

The reported event was unconfirmed since the reported failure could not be reproduced.The device was used for treatment.The device met specifications.The device was not related to the reported failure as the failure was unconfirmed.Visual evaluation of the returned sample noted one opened (no original packaging), used silicone foley.Visual inspection of the sample noted that there was no mushroom on the balloon upon return.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 60:40.The balloon rested for 30 minutes without leaks and passively deflated in 58.45 seconds without issue or cuffing, returning 10ml of solution.This met the specification as the "balloon must not cuff after deflation" per the standard.The distance between the inflation notch and the end of the shaft was measured (0.9665') and was within specification (0.97" ± 0.030").A potential root cause could not be found since the reported event was unconfirmed.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: ¿peel to open c.R.Bard, inc.Covington, ga 30014 1-800-526-4455 www.Bardmedical.Com bardex® all-silicone foley catheter catheter shaft made entirely of silicone elastomer pd-50205 11/00 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.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone 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 use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Bard and bardex are registered trademarks 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.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Released" 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 there was an issue with the foley catheter upon removal.The complainant reported that it took 9 attempts to remove the catheter and when they finally removed it, there was bleeding noted.The catheter was reportedly observed to have 'rolled' on itself in the balloon area upon removal.The complainant noted that the associates cut the tip off the catheter to be able to share what was experienced.No medical intervention was reported.The associates reportedly used another catheter to help troubleshoot, and experienced the same issue with the rolling.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9820140
• MDR Text Key: 186697352
• Report Number: 1018233-2020-01751
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

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: 10/15/2020
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGDX1806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1