MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 MAGIC3 GO¿ INTERMITTENT URINARY CATHETER; INTERMITTENT CATHETER

Model Number	51814
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a urinary tract infection (uti) from fall of 2022 to on (b)(6) 2023 by using the magic3 go intermittent catheter of different lot numbers: jufv0450, lot#: jufz0455, lot#: jufz0782, lot#: jufz0926, lot#: jugp9222, lot#: jugq3272, lot#: jugr0160, lot#: jugr1384, lot#: jugu1966.It was unknown what medical intervention was provided.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "patient sensitivity to materials".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "instructions for use": review the selfcatheterization 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.

• Brand Name: MAGIC3 GO¿ INTERMITTENT URINARY CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17364141
• Report Number: 1018233-2023-05354
• Device Sequence Number: 5152173
• Product Code: EZD
• UDI-Device Identifier: 00801741097898
• UDI-Public: (01)00801741097898
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/28/2025
• Device Model Number: 51814
• Device Catalogue Number: 51814
• Device Lot Number: JUGP9222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female