MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 GO INTERMITTENT URINARY CATHETER, PEDIATRIC, 6 FR.; MAGIC 3 CATHETER

Model Number	52806G
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿difficult insertion" with a potential root cause of ¿outside diameter is too large, rough or irregular shape protrusions".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use 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.".
Event or Problem Description
It was reported difficult to insert the catheter as it was larger than usual.The patient was not able to fully insert the catheter for use.

• Brand Name: MAGIC3 GO INTERMITTENT URINARY CATHETER, PEDIATRIC, 6 FR.
• Common Device Name: MAGIC 3 CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8804617
• Report Number: 1018233-2019-04035
• Device Sequence Number: 18918087
• Product Code: EZD
• UDI-Device Identifier: 00801741136856
• UDI-Public: (01)00801741136856
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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: Lay User/Patient
• Device Model Number: 52806G
• Device Catalogue Number: 52806G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1