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

Model Number	71810
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/03/2021
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 intermittent catheters did not seem to have any hydrophilic coating on them, or it seemed to be on the handle and not on the insertion tip and making it painful during insertion.It was also stated that some catheters seemed more like a 12ch instead of 10ch on rare occasions and made insertion painful.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "operator error".The lot number was 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.1.Always wash hands prior to use.2.Open the catheter package by peeling the tab upwards with the aid of the finger hole.3.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.4.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.5.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).6.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: 7.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.8.Wash hands." h11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that some intermittent catheters did not seem to have any hydrophilic coating on them or it seemed to be on the handle and not on the insertion tip and making it painful during insertion.It was also stated that some catheters seemed more like a 12 ch instead of 10 ch on rare occasions and made insertion painful.

• Brand Name: HYDROSIL GO INTERMITTENT URINARY CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12381753
• Report Number: 1018233-2021-05232
• Device Sequence Number: 4688066
• Product Code: EZD
• UDI-Device Identifier: 00801741097973
• UDI-Public: (01)00801741097973
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: 71810
• Device Catalogue Number: 71810
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other