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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ HYDROPHILIC INTERMITTENT CATHETER, FEMALE; MAGIC 3 CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ HYDROPHILIC INTERMITTENT CATHETER, FEMALE; MAGIC 3 CATHETER Back to Search Results
Model Number 51614S
Device Problems Nonstandard Device (1420); Appropriate Term/Code Not Available (3191)
Patient Problems No Patient Involvement (2645); 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.The device was not returned.
 
Event Description
It was reported that the magic 3 catheter failed the visual analysis evaluation.Fda customs detained this product at the border where it was randomly selected to be sampled and sent to an fda selected laboratory for inspection.
 
Manufacturer Narrative
The device was not returned for evaluation.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: a.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.B.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.C.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: a.Hold the funnel end and remove the catheter from the packaging.B.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 magic 3 catheter failed the visual analysis evaluation.Fda customs detained this product at the border where it was randomly selected to be sampled and sent to an fda selected laboratory for inspection.
 
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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
MDR Report Key8304703
MDR Text Key135157643
Report Number1018233-2019-00588
Device Sequence Number1
Product Code OHR
UDI-Device Identifier00801741072499
UDI-Public(01)00801741072499
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number51614S
Device Catalogue Number51614S
Was Device Available for Evaluation? No
Date Manufacturer Received03/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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