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

Model Number	71812
Health Effect - Clinical Code	Discomfort (2330)
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 catheters were not smooth.The nurse used them with a patient, to teach him intermittent catheterisation.The catheters were rough and uncomfortable for the patient.There was no medical intervention.
Additional Manufacturer Narrative
The reported event could not be confirmed.While the samples passed the visual evaluation, a lubricity functional evaluation could not be performed since the samples were inadvertently left open/exposed.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: ¿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." (b)(4).
Event or Problem Description
It was reported that the catheters were not smooth.The nurse used them with a patient, to teach him intermittent catheterisation.The catheters were rough and uncomfortable for the patient.There was no medical intervention.

• Brand Name: HYDROSIL GO¿ INTERMITTENT URINARY CATHETER
• Common Device Name: HYDROSIL
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6817777
• Report Number: 1018233-2017-04420
• Device Sequence Number: 1443910
• Product Code: EZD
• UDI-Device Identifier: 00801741097997
• UDI-Public: (01)00801741097997
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K150345
• 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): 11/30/2017

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: 06/28/2018
• Device Model Number: 71812
• Device Catalogue Number: 71812
• Device Lot Number: JUAT0640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1