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

Model Number	175806N
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Irritability (2421)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 or Problem Description
It was reported that the silicone catheter placed and balloon inflated to 2 ml.The patient felt irritable intermittently for next two hours and no urine collected in catheter tubing.It was further stated that the balloon attempted to be deflated, but only drops came out.After the patient finished voiding, silicone catheter removed and balloon found to be blown.Per follow up with customer via mail on (b)(6) 2021, there was no adverse event noted, except that a new catheter had to be inserted.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.The device had not met specification as the reported failure was able to be reproduced.The product was used for treatment.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone foley catheter.Visual inspection of the sample noted balloon burst down the entire length of the balloon.This was out of specification per inspection procedure, which states, ¿catheter must not be stretched, wrinkled or deformed." a potential root cause for this failure could be high modulus silicone.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.1.Open the product using standard hospital technique for handling sterile product.2.The catheter may be lubricated with standard water soluble lubricant, to facilitate insertion.3.Insert the catheter following preferred aseptic technique.4.Once the catheter is correctly seated in the bladder, inflate the catheter with 1.5 ml of sterile water.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.If you notice slow or no deflation, reseat 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." 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 or Problem Description
It was reported that the silicone catheter placed and balloon inflated to 2 ml.The patient felt irritable intermittently for next two hours and no urine collected in catheter tubing.It was further stated that the balloon attempted to be deflated, but only drops came out.After the patient finished voiding, silicone catheter removed and balloon found to be blown.Per follow up with customer via mail on (b)(6) 2021, there was no adverse event noted, except that a new catheter had to be inserted.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11862960
• Report Number: 1018233-2021-02956
• Device Sequence Number: 14303216
• Product Code: EZL
• UDI-Device Identifier: 00801741034268
• UDI-Public: (01)00801741034268
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 175806N
• Device Catalogue Number: 175806N
• Device Lot Number: NGEU2410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown