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

Model Number	33616
Health Effect - Clinical Codes	Pain (1994); 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 the silastic foley catheter was difficult to remove and was getting stuck in the urinary tract.The complainant reported that the catheter was cut in order for the balloon to be properly deflated, and the catheter was removed from the patient.The patient reportedly experienced pain.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduced.Nine unopened silastic catheters were returned.The sampling plan was used per general inspection.Therefore, three sample was chosen for evaluation.The 3 catheters were opened.The 3 catheters were inflated with 10ccs of air using a leur lock syringe.The catheters were passively deflated with no issues.The process was repeated with 10 ccs of water, there were no issues with inflation or deflation.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "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." 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 silastic foley catheter was difficult to remove and was getting stuck in the urinary tract.The complainant reported that the catheter was cut in order for the balloon to be properly deflated, and the catheter was removed from the patient.The patient reportedly experienced pain.No medical intervention was reported.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: SILASTIC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9544569
• Report Number: 1018233-2020-00052
• Device Sequence Number: 3444987
• Product Code: EZL
• UDI-Device Identifier: 00801741020063
• UDI-Public: (01)00801741020063
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 12/31/2022
• Device Model Number: 33616
• Device Catalogue Number: 33616
• Device Lot Number: NGCY3534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1