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

Model Number 51514

Device Problems Improper Chemical Reaction (2952); Therapeutic or Diagnostic Output Failure (3023)

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 patient stated that the last replacement order received was all dried up.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "viscometer failure or mechanical failure".The lot number was unknown; therefore, the device history record could not be reviewed.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.1.Release the water prior to opening the sealed catheter pouch: a.Apply pressure to the foil packet to release the water.B.Ensure all water is released from the foil packet.2.Wet the catheter a.Hold package with printed side up.B.Tip package end-to-end three to six times to wet catheter.This movement is required so that the water transfers back and forth over the catheter to fully wet the hydrophilic coating.3.Use the catheter a.Peel back package to expose funnel end of catheter.B.If desired, use the self-adhesive tape on the package to temporarily attach the pouch to any dry vertical surface.C.Remove catheter and use according to physician¿s instructions." 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.H3 other text : the device was not returned.

Event Description

It was reported that the patient stated that the last replacement order received was all dried up.

• Brand Name: MAGIC3 INTERMITTENT CATHETER
• Type of Device: MAGIC 3 FEMALE INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10523590
• MDR Text Key: 207708128
• Report Number: 1018233-2020-05832
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741068188
• UDI-Public: (01)00801741068188
• 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,distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 51514
• Device Catalogue Number: 51514
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1