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

Model Number 53614G

Device Problems Difficult to Insert (1316); Product Quality Problem (1506); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the magic3 catheter was not lubricated all the way, which made it difficult to insert.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the magic3 catheter was not lubricated all the way, which made it difficult to insert.

Manufacturer Narrative

The reported event was unconfirmed.The visual evaluation noted 6 unopened samples in original packaging.No damage was noted on exterior of the packaging.Dip line and hydrophilic coating were present.A organoleptic test was performed and the lubricious coating material remained on 4 catheters after more than 10 wipes and 2 catheters for 5 wipes.All catheters passed the organoleptic test.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: "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.".

Event Description

It was reported that the magic3 catheter was not lubricated all the way, which made it difficult to insert.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE
• Type of Device: MAGIC 3 CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8285446
• MDR Text Key: 134413042
• Report Number: 1018233-2019-00457
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741069772
• UDI-Public: (01)00801741069772
• Combination Product (y/n): N
• PMA/PMN Number: K033477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2023
• Device Model Number: 53614G
• Device Catalogue Number: 53516G
• Device Lot Number: JUCS0365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1