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

Model Number 53614GS

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the catheter was folded in half inside the packaging creating a kink.The user was unable to use the device.

Event Description

It was reported that the catheter was folded in half inside the packaging creating a kink.The user was unable to use the device.

Manufacturer Narrative

The reported event was confirmed.Received 2 unopened magic3 intermittent catheter insertion supply kits for evaluation.The samples were visually inspected for printing information in the package, completed package sealing without openings and free of damages (holes, perforations, tears, pleats or channels).During the visual inspection it was noted that the samples were bent.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "intended use: the catheter is intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/ precautions and adverse reactions.Wash your hands thoroughly with soap and water.Release the sterile water from the foil packet.Tip the catheter pouch end-to-end three to six times so the water moves back and forth to thoroughly wet the catheter surface.Peel open the pack at the funnel end just enough to expose the insertion sleeve.Don¿t remove the catheter yet.Use the adhesive tab at the funnel end of the pack to stick the pack to a nearby vertical surface while preparing to catheterize.Wash the area around the meatus before catheterizing.Wash your hands again.Hold the insertion sleeve with your dominant hand and squeeze it to grip the catheter shaft as you remove the catheter from the pack.Next, hold the catheter funnel above the insertion sleeve with your other hand and slide the insertion sleeve down the shaft, stopping at about 6¿ from the tip.Release the funnel.Using the insertion sleeve to hold the catheter firmly, gently pass the tip of the catheter into your urethra until the insertion sleeve nears the meatus.Repeat until urine starts to flow.Try to keep the catheter steady until urine stops flowing.When urine stops flowing, slowly withdraw the catheter, stopping if flow starts again, until the last few drops have drained.Finish by disposing of the catheter and its packaging.Wash your hands with soap and water.Warning: this is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.Urethral catheter for urological use only.Discard after use.Made of silicone elastomer." (b)(4).

• Brand Name: MAGIC3¿ HYDROPHILIC INTERMITTENT CATHETER, MALE
• Type of Device: MAGIC 3 CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; parque industrial aeropuerto; covington GA 30014
• MDR Report Key: 6780468
• MDR Text Key: 82672692
• Report Number: 1018233-2017-04169
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 00801741072659
• UDI-Public: (01)00801741072659
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2019
• Device Model Number: 53614GS
• Device Catalogue Number: 53614GS
• Device Lot Number: JUBR2588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1