MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 GO PEDIATRIC CATHETER WITH SUREGRIP; INTERMITTENT CATHETER

Model Number	52810G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067); Urinary Tract Infection (2120)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intermittent catheter possibly caused urinary tract infection.It took place a month ago and had received antibiotics about 3 times to overcome urinary tract infection.Per follow up via phone on (b)(6) 2023, it was reported that the customer received a voluntary emergency notice from bd regarding a recall for a nonconformity with the magic go 14 fr catheters.They were reported in a company-wide notice as having nonsterile coude, and they happened to be one of those impacted by it.At the time, they were sent out from 180 medical.This led to numerous bladder infections and sepsis, and this made things difficult for them as they could not walk.They still had samples available and provided the lot# jugw1445.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 these intermittent catheters caused patient an infection and was hospitalized and caught tetanus.It was unknown what medical intervention was provided for infection and tetanus.Per follow up via phone on 22may2023, it was reported that the customer received a voluntary emergency notice from bd regarding a recall for a nonconformity with the magic go 14 fr catheters.They were reported in a company-wide notice as having nonsterile coude and they happened to be one of those impacted by it.At the time, they were sent out from 180 medical.This led to numerous bladder infections and sepsis, and this made things difficult for them as they could not walk.They still had samples available and provided the lot# jugw1445.Per sample returned on 14jun2023, customer had returned with material #50814g and bacth#juft0536.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to ¿patient sensitivity to materials¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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: "indications for use: the magic 3 go® intermittent urinary catheter is intended for urological use only.It is intended for use by adult and pediatric patients of all ages for bladder management including urine drainage, collection, and measurement.The device is passed to the urinary bladder via the urethra.Contraindications: none known.Warnings: this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Precautions: inspect the catheter before use.Do not use the product if the device or packaging is damaged.Self-catheterization should follow the plan of care and advice given by your healthcare practitioner and be carried out only in accordance with the instructions for use provided.Please consult your healthcare practitioner if any conditions occur which create concern and/or difficulty during catheterization.Adverse reactions: urinary tract infection.Bleeding from the urethra.Irritation of the urethra.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." 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 PEDIATRIC CATHETER WITH SUREGRIP
• 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: 17071263
• Report Number: 1018233-2023-04065
• Device Sequence Number: 6129633
• Product Code: EZD
• UDI-Device Identifier: 00801741136870
• UDI-Public: (01)00801741136870
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 09/28/2025
• Device Model Number: 52810G
• Device Catalogue Number: 52810G
• Device Lot Number: JUGW1445
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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: Required Intervention
• Patient Sex: Male