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.
Event or Problem Description
It was reported that the magic 3 catheter had a lack of lubricity.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation noted 29 unopened magic 3 intermittent catheters in original packaging.No damage noted on exterior of packaging.Dip line and hydrophilic coating were present.The samples were tested according to general inspection level ii/single sampling plan.Performed organoleptic test.Lubricious coating material remained on all catheters tested after more than 10 wipes.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: "intended use the catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established.The device is not intended to be used as a treatment for active urinary tract infection.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/ precautions and adverse reactions.Instructions for use the catheter becomes slippery when wetted with water, eliminating the need for a separate lubricant.For your added convenience, this catheter is packaged with its own sterile water.Simply release the water from its foil packet and then tip the un-opened catheter package end-to-end.The catheter acts like a magnet to attract the water and activate its slippery coating.Follow these steps for best results." h11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the magic 3 catheter had a lack of lubricity.

• 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: 8635584
• Report Number: 1018233-2019-02686
• Device Sequence Number: 19351121
• 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: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: 01/31/2024
• Device Model Number: 53514
• Device Catalogue Number: 53514
• Device Lot Number: JUDN0367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/16/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1