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

Model Number 51614S

Device Problem Product Quality Problem (1506)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿viscosity too high/low¿ with a potential root cause of ¿operator error or mechanical failure¿.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "for urological use only.Urinary catheters are intended for use for bladder management including urine drainage, collection and measurement.The devices are passed to the urinary bladder via the urethra.This is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/precautions and adverse reactions.1.Wash your hands thoroughly with soap and water.2.Prior to opening the sealed catheter pouch, apply pressure to the foil packet to release the water.Ensure all water is released from the foil packet.3.Wet the catheter by holding the package with the printed side up and tip the 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.4.Peel open the pack at the funnel end to expose approximately 4¿ of the catheter.Don¿t remove the catheter yet.Use the adhesive tab at the funnel end of the pack to stick the pack to a nearby dry vertical surface while preparing to catheterize.5.Wash the area around the meatus before catheterizing.6.Wash your hands again.7.Using the catheter with sure-grip¿ sleeve: hold the sure-grip¿ sleeve with your dominant hand and squeeze it to hold the catheter shaft as you remove the catheter from the pack.Next, hold the catheter funnel above the sure-grip¿ sleeve with your other hand and slide the sure-grip¿ sleeve down the shaft, stopping at about 6¿ from the tip.Release the funnel.While gripping the catheter with the sure-grip¿ sleeve, gently pass the tip of the catheter into your urethra until the sure-grip¿ sleeve nears the meatus.If there is no urine flow, loosen the tension on the sure-grip¿ sleeve to allow it to slide back towards the funnel end.Re-grip sure-grip¿ sleeve and continue to insert the catheter into the urethra.Repeat until urine starts to flow.Without sure-grip¿ sleeve: hold the funnel end and remove the catheter from the packaging.Gently pass the tip of the catheter into your urethra and advance the catheter until urine starts to flow.8.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.9.Finish by disposing of the catheter and its packaging.Wash your hands with soap and water.".

Event Description

It was reported that the catheters lacked lubricity causing painful insertion.No medical intervention was reported.It is unknown if the patient was able to fully insert and void.

• Brand Name: MAGIC3¿ HYDROPHILIC INTERMITTENT CATHETER, FEMALE
• Type of Device: MAGIC 3 CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10043136
• MDR Text Key: 190510384
• Report Number: 1018233-2020-03101
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 00801741072499
• UDI-Public: (01)00801741072499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 51614S
• Device Catalogue Number: 51614S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1