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

Model Number 175816

Device Problems Inflation Problem (1310); Difficult to Remove (1528)

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

Event Date 01/15/2020

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 the foley did not inflate properly.Per additional information received, the health professional was only able to get 2mls in the foley, and it would not let him put any more.

Manufacturer Narrative

The reported event was confirmed.The device had not meet specifications.The product was intended to be used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), silicone foley catheter.Visual inspection of the sample noted no obvious visible defects.An attempt was made to the catheter balloon with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), but the solution was unable to advance into the balloon.The catheter balloon was dissected to find that the inflation notch was not completely perforated.This is out of specification per inspection procedure, which states, "verify that the eye and notch punches are complete and in within the applicable drawing for each fr.Size." 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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use.1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Pour cleansing solution onto prep balls.6.Open catheter lubricating jelly.7.Remove top tray.8.Open plastic pouch surrounding catheter.9.Lubricate catheter.10.Prepare patient with saturated prep balls.(retain one ball for later use.) 11.Proceed with catheterization in usual manner.To inflate catheter, insert tip of water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water (10cc).12.Hang the bag near the foot of the bed by using string and/or hook.13.Use sheeting clip to secure drainage tube to draw sheet.14.The urine meter may be emptied in two ways: a.To empty into the bag, grasp the bottom of the meter and lift up.To provide better meter drainage, lifting again is recommended.B.To empty urine meter into receptacle, twist green portion of drain valve to the left; to close, twist green portion of the drain valve to the right.15.To empty bag: a.Remove outlet tube from housing; gently squeeze connector arms and pull tube from housing.B.Release clamp and empty bag.C.After emptying, reclamp outlet tube and slide connector into housing until connector arms engage.Engage disengage control fit connector 17.Periodic observations of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed." 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 the foley did not inflate properly.Per additional information received, the health professional was only able to get a max of 2mls into the foley.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: LUBRISIL FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9678019
• MDR Text Key: 183947614
• Report Number: 1018233-2020-00845
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGDW1687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1