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

Model Number	71814
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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.
Event or Problem Description
It was reported that the catheter was wavy, therefore not usable.
Event or Problem Description
It was reported that the catheter was wavy,therefore not usable.
Additional Manufacturer Narrative
The reported event was confirmed.The visual evaluation noted 2 opened and unused hydrosil go intermittent catheters were received.Both catheters were not completely straight.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: "device description the hydrosil 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 hydrosil go¿ intermittent urinary catheter is intended for urological use only.It is intended for use by adult female patients 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.Adverse reactions urinary tract infection bleeding from the urethra irritation of the urethra".

• Brand Name: MAGIC3 GO¿ INTERMITTENT URINARY CATHETER
• Common Device Name: INTERMITTENT SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8249359
• Report Number: 1018233-2019-00257
• Device Sequence Number: 16558653
• Product Code: EZD
• UDI-Device Identifier: 00801741098017
• UDI-Public: (01)00801741098017
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: Health Professional
• Device Expiration Date: 12/28/2019
• Device Model Number: 71814
• Device Catalogue Number: 51814
• Device Lot Number: JUAX0714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1