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

Model Number	165822
Health Effect - Clinical Code	No Information (3190)
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 bard 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 bard.
Event or Problem Description
It was reported that the statlock device would not stay closed over the 22fr silicone catheters the patient used.The patient reported that this caused the statlock device to rotate during use and twist the catheter, preventing urine flow.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.Received 4 photos showing a catheter connected to the statlock.Per visual inspection of the photos, no issues on the catheter were noted.Functional evaluation could not be performed due to no physical sample was returned for evaluation, only pictures were received.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "caution: do not aspirate urine through drainage funnel wall.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
Event or Problem Description
It was reported that the statlock device would not stay closed over the 22fr silicone catheters the patient used.The patient reported that this caused the statlock device to rotate during use and twist the catheter, preventing urine flow.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7229012
• Report Number: 1018233-2018-00273
• Device Sequence Number: 11261090
• Product Code: EZL
• UDI-Device Identifier: 00801741029783
• UDI-Public: (01)00801741029783
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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: 165822
• Device Catalogue Number: 165822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1