MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ INTERMITTENT CATHETER; MAGIC 3 CATHETER

Model Number	53514
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that the magic 3 catheter had a lack of lubricity making it difficult to insert.
Additional Manufacturer Narrative
This report is being submitted past the regulatory timeframe.The device was not returned for evaluation.A potential failure mode could be ¿inadequately mixed solution¿.A potential root cause for this failure mode could be ¿incorrect mixer speed or incorrect component sequence¿.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state 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.".The device was not returned.
Event or Problem Description
It was reported that the magic 3 catheter had a lack of lubricity making it difficult to insert.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• Common Device Name: MAGIC 3 CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8467203
• Report Number: 1018233-2019-01628
• Device Sequence Number: 11253362
• Product Code: MJC
• UDI-Device Identifier: 00801741068515
• UDI-Public: (01)00801741068515
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K033477
• 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): 05/24/2019

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: 53514
• Device Catalogue Number: 53514
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1