MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 8F 10" MAGIC3 GO PEDIATRIC CATHETER W/SURE-GRIP; MAGIC 3 CATHETER

Catalog Number	52808G
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Swelling (2091); Urinary Tract Infection (2120); Fungal Infection (2419)
Type of Reportable Event	Serious Injury
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.The device was not returned.
Event or Problem Description
It was reported that the catheters lacked lubricity.The patient experienced bleeding, inflammation, swelling, a uti, and a yeast infection.The patient has been prescribed medication by their physician.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use was found adequate and states the following: "please read all instructions before using this device.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.Device description the magic3 go® intermittent urinary catheter is a silicone tube inserted into the urethra for the purpose of draining the bladder of urine.Not made with natural rubber latex does not contain dehp indications for use the magic3 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.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, use the adhesive label(s) to hang the package on a nearby dry vertical surface while preparing to catheterize.4.Clean the opening to the urethra ¿ and the surrounding area.Wipe from front to back to avoid fecal contamination.Wash your hands again.5.Hold the insertion sleeve with your dominant hand and squeeze it to grip the catheter shaft as you remove the catheter from the pack.Next, hold the catheter funnel above the insertion sleeve with your other hand and slide the insertion sleeve down the shaft, stopping at about 6¿ from the tip.Release the funnel.Using the insertion sleeve to hold the catheter firmly, gently pass the tip of the catheter into your urethra until the insertion sleeve nears the meatus.Repeat until urine starts to flow.6.Keep the catheter steady until urine stops flowing.When urine stops flowing, slowly withdraw the catheter, stopping if flow starts again, until the last few drops have drained.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." patient code: (b)(4).
Event or Problem Description
It was reported that the catheters lacked lubricity.The patient experienced bleeding, inflammation, swelling, a uti, and a yeast infection.The patient has been prescribed medication by their physician.

• Brand Name: 8F 10" MAGIC3 GO PEDIATRIC CATHETER W/SURE-GRIP
• Common Device Name: MAGIC 3 CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7876953
• Report Number: 1018233-2018-04187
• Device Sequence Number: 2061750
• Product Code: EZD
• UDI-Device Identifier: 00801741136863
• UDI-Public: (01)00801741136863
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: 04/28/2020
• Device Catalogue Number: 52808G
• Device Lot Number: JUCR0295
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 09/29/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/11/2018
• 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: Required Intervention