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

Model Number	33416
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 device was not returned.
Event or Problem Description
It was reported that on (b)(6) 2018 a bd associate received a call from the customer stating that three foley catheters were unable to inflate with the sterile water.He noted that when he attempted to inflate the device, the shaft was blown up but the balloon itself did not.This event occurred prior to use.A bubble formed at the point of the syringe.The water went into the first part of the catheter shaft but no further.No obstructions could be seen in the tubing.The user was experienced.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿english bard® foley catheter warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter.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.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.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.Units do not use if package is damaged single use do not resterilize 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.Contains or presence of natural rubber latex.Caution: this product contains natural rubber latex which may cause allergic reactions.Keep away from sunlight valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 15cc balloon: use 20ml sterile water 20cc balloon: use 25ml sterile water 30cc balloon: use 35ml sterile water 40cc balloon: use 45ml sterile water 75cc balloon: use 80ml sterile water do not exceed recommended capacities.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.Refer to direct unit label for sterilization method utilized sterilized by radiation or sterilized by ethylene oxide bard, bardex, and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.".
Event or Problem Description
It was reported that on 09nov2018 a bd associate received a call from the customer stating that three foley catheters were unable to inflate with the sterile water.He noted that when he attempted to inflate the device, the shaft was blown up but the balloon itself did not.This event occurred prior to use.A bubble formed at the point of the syringe.The water went into the first part of the catheter shaft but no further.No obstructions could be seen in the tubing.The user was experienced.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8118477
• Report Number: 1018233-2018-05703
• Device Sequence Number: 13536714
• Product Code: EZL
• UDI-Device Identifier: 00801741019982
• UDI-Public: (01)00801741019982
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: 33416
• Device Catalogue Number: 33416
• Device Lot Number: NGBN4265
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1