MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DT ALL SILICONE F/M, 14CH (USED ONLY IN THE UK); ALL- SILICONE FEMALE FOLEY

Catalog Number D166114

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 03/04/2019

Event Type  Injury  

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 on (b)(6) 2019, when the catheter was removed, the catheter had broken and the tip was retained in the bladder.The catheter was retained and then when the patient had a cystoscopy in early june, the tip was removed.The break is irregular and unclear how this has happened.The surgeon went to insert another of the patient's catheters (same batch) and this started to break when it was being inserted.The entire catheter has been retained (not inserted) and an ekhuft catheter was inserted instead.The break is again irregular.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted one opened (without original packaging), silicone female foley catheter.Visual inspection of the sample noted that the upper catheter was torn at an angle with a missing tip.The break was jagged and uneven, coming to a point below the balloon.A portion of the balloon was also missing.This is out of spec per inspection procedure which states, "cuts in lumens are not allowed." and "tips to be straight relative to shaft, transition between the shaft and tip must be smooth, ridges, lines or gouges not permitted, tip not to be incomplete or malformed, scratched and/or with channels." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿a potential root cause for this failure could be "the eyes or tube are pinched by mold tip inserts." 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: ¿warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone.English warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Units this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.For urological use only.Do not use if package is damaged.Bard, bardex, bardia, biocath and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.Single use only.Do not resterilize consult instructions for use.C.R.Bard, inc.Covington, ga 30014 usa 1 800 526 4455 www.Bardmedical.Com manufacturer: to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.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 necessary, 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." correction: b1, d4, e1.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 on 04/03/2019, when a catheter was removed, the catheter had broken and the tip was retained in the bladder.The catheter was retained and then, when patient had a cystoscopy in early june, the tip was removed.The break is irregular and unclear how this has happened.The surgeon went to insert another of the patient's catheters (same batch) and this started to break when it was being inserted.The entire catheter has been retained (not inserted) and an ekhuft catheter was inserted instead.The break is again irregular.Per additional information received, the patient had a condition called fowler syndrome.The catheters were not brittle during the second incident, the break was noticed before complete placement of the catheter, the catheter was removed and another catheter was placed.

• Brand Name: DT ALL SILICONE F/M, 14CH (USED ONLY IN THE UK)
• Type of Device: ALL- SILICONE FEMALE FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8789449
• MDR Text Key: 150995450
• Report Number: 1018233-2019-03910
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Catalogue Number: D166114
• Device Lot Number: NGBT2032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR