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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE; MAGIC 3 CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE; MAGIC 3 CATHETER Back to Search Results
Model Number 53514G
Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
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 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 magic 3 catheter packaging was not sealed.Allegedly, there was an open slit along the seam of the package.The complainant stated that the catheters were not exposed to any high temperatures of 100f or above.
 
Manufacturer Narrative
The reported event was confirmed.Visual evaluation noted 4 unused magic 3 intermittent catheters in original packaging.Three of the packages had an opening in the seal (3.5", 3.0", 5.0") on the tip end of the catheter.The fourth package had an opening in the seal (3.5") on the funnel end of the catheter.All four packages had evidence of seal transfer present.The rest of the seal on all of the catheters were still intact.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use was found adequate and states 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.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.Active ingredient the catheter contains 10.2 +/- 2.0 micrograms nitrofurazone (5 nitro-2-furaldehyde semicarbazone) per mm2.The amount of nitrofurazone per mm2 remains constant regardless of catheter french size.The funnel end of the catheter is excluded in calculating the catheter surface area.".
 
Event Description
It was reported that the magic 3 catheter packaging was not sealed.Allegedly, there was an open slit along the seam of the package.The complainant stated that the catheters were not exposed to any high temperatures of 100f or above.
 
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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 Key7847547
MDR Text Key119496424
Report Number1018233-2018-03972
Device Sequence Number1
Product Code MJC
UDI-Device Identifier00801741069710
UDI-Public(01)00801741069710
Combination Product (y/n)N
PMA/PMN Number
K033477
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/28/2023
Device Model Number53514G
Device Catalogue Number53514G
Device Lot NumberJUCP0150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2018
Date Manufacturer Received11/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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