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

Model Number	33416
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2016
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 the nurse was unable to deflate the balloon.Per additional information, the nurse went to the client's house for a biweekly catheter change.The catheter was cut below the valve but the balloon supposedly would not deflate.The patient had to be sent to (b)(6) hospital's emergency room but the catheter balloon still could not be deflated and client was sent home.The following day, the client went by ambulance to (b)(6) hospital and after seeing 3 different doctors the balloon was manually deflated, and a new catheter was inserted.The client is now refusing to use this product again as this is the 3rd time this has occurred with this brand/type and size of bard catheter.
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 state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter.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.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.Do not use if package is damaged.Single use do not resterilize.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.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.Refer to direct unit label for sterilization method utilized sterilized by radiation sterilized by ethylene oxide.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.Sterilized by radiation sterilized by ethylene oxide" (b)(4).
Event or Problem Description
It was reported that the nurse was unable to deflate the balloon.Per additional information, the nurse went to the client's house for a biweekly catheter change.The catheter was cut below the valve but the balloon supposedly would not deflate.The patient had to be sent to (b)(6) hospital's emergency room but the catheter balloon still could not be deflated and client was sent home.The following day, the client went by ambulance to (b)(6) hospital and after seeing 3 different doctors the balloon was manually deflated, and a new catheter was inserted.The client is now refusing to use this product again as this is the 3rd time this has occurred with this brand/type and size of bard catheter.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: SILASTIC FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7020492
• Report Number: 1018233-2017-05802
• Device Sequence Number: 1238860
• 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: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2017

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: 03/31/2020
• Device Model Number: 33416
• Device Catalogue Number: 33416
• Device Lot Number: NGZI3654
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 11/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1