MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY; SURESTEP FOLEY TRAY

Model Number	A800361
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.
Event or Problem Description
It was reported that when removing the foley catheter, a health professional attempted to withdraw water from the balloon with syringe and only 5cc withdrew despite multiple attempts.The catheter was cut without release of remainder fluid.Health care professional then attempted to "milk" the bulb without success.The foley was removed with partially inflated balloon.
Event or Problem Description
It was reported that when removing the foley catheter, a health professional attempted to withdraw water from the balloon with syringe and only 5cc withdrew despite multiple attempts.The catheter was cut without release of remainder fluid.Health care professional then attempted to "milk" the bulb without success.The foley was removed with partially inflated balloon.
Additional Manufacturer Narrative
The reported event was found inconclusive due to the way the sample was received.Per the evaluation, the sample was classified as a poor sample condition and several tests could not be carried out to determine the root cause of the problem.The exact time of how and when problem occurred could not be determined.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿to deflate catheter balloon: gently, insert a 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, 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 permitted by hospital protocol, the valve arm may be severed.If the tails, contact an adequately trained professional for assistance as detected by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.".

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY
• Common Device Name: SURESTEP FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8388652
• Report Number: 1018233-2019-01156
• Device Sequence Number: 14184610
• Product Code: EZC
• UDI-Device Identifier: 00801741073939
• UDI-Public: (01)00801741073939
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: Health Professional
• Device Model Number: A800361
• Device Catalogue Number: A800361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1