MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 HYDROSIL GO¿ INTERMITTENT URINARY CATHETER; HYDROSIL INTERMITTENT CATHETER

Model Number	71810
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be insufficient drainage of urine from bladder due to a potential root cause of inner diameter of drainage lumen too small.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: "review the self-catheterization procedure with a healthcare professional.Always wash hands prior to use.Open the catheter package by peeling the tab upwards with the aid of the finger hole.If desired, hang the package with the adhesive surface on the inner side of the tab to a nearby dry vertical surface while preparing to catheterize.Positioned comfortably with thighs spread apart, clean the opening to the urethra ¿ and the surrounding area.Wipe from front to back to avoid fecal contamination.Wash your hands again.Remove the catheter with the aid of the insertion handle and advance the catheter tip into the urethra.Slowly and gently insert the catheter into the urethra until urine begins to flow (approximately 1-1.5" or 2.5-3.8 cm).When urine stops flowing, begin to withdraw the catheter.It is recommended to slowly rotate the catheter during withdrawal, stopping each time urine begins to flow.Check the color, odor and clarity of the urine.Any changes may need to be reported to a health care professional.Disposal place the catheter back into the package and dispose in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Do not flush down the toilet.Wash hands.".
Event or Problem Description
It was reported that the hydrosil intermittent catheter was not completely draining the patient's bladder.

• Brand Name: HYDROSIL GO¿ INTERMITTENT URINARY CATHETER
• Common Device Name: HYDROSIL INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8881549
• Report Number: 1018233-2019-04646
• Device Sequence Number: 2206637
• Product Code: EZD
• UDI-Device Identifier: 00801741097973
• UDI-Public: (01)00801741097973
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2019

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 Model Number: 71810
• Device Catalogue Number: 71810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1