MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 GO¿ INTERMITTENT URINARY CATHETER; 16 FR MAGIC 3 CATHETER

Catalog Number	53818G
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); 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 patient allegedly experienced some self limited bleeding during the insertion of the catheter.The patient was not able to fully insert the catheter for use.No medical intervention was reported.
Event or Problem Description
It was reported that the patient allegedly experienced some self limited bleeding during the insertion of the catheter.The patient was not able to fully insert the catheter for use.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was unconfirmed.The visual evaluation noted 5 unopened samples in original packaging.No damage was noted on the exterior of the packaging.Dip line and hydrophilic coating were present.The catheters outer dimensions measured to be 0.2350" and 0.2315", which were found to be within specification (0.236" +/- 0.013").The samples were tested according to the general inspection level ii/single sampling plan.Coefficient of friction was performed and each sample was cut in half in order to test as a pair.Kinetic cof was found to be within specification (<0.400) for all catheters tested.All samples were able to drain normally.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: "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".

• Brand Name: MAGIC3 GO¿ INTERMITTENT URINARY CATHETER
• Common Device Name: 16 FR MAGIC 3 CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8301303
• Report Number: 1018233-2019-00562
• Device Sequence Number: 1663249
• Product Code: EZD
• UDI-Device Identifier: 00801741136986
• UDI-Public: (01)00801741136986
• 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,Followup
• Report Date (Section B): 05/22/2019

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 Expiration Date: 07/28/2021
• Device Catalogue Number: 53818G
• Device Lot Number: JUCV0134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1