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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER INTERMITTENT MAGIC3 ANTIBACTERIAL PRECONNECTED TRAY 14FR 20BX; MAGIC 3 CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER INTERMITTENT MAGIC3 ANTIBACTERIAL PRECONNECTED TRAY 14FR 20BX; MAGIC 3 CATHETER Back to Search Results
Catalog Number 53814
Device Problems Difficult to Insert (1316); Product Quality Problem (1506); Fitting Problem (2183)
Patient Problems No Consequences Or Impact To Patient (2199); Discomfort (2330)
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 catheters were not lubricated enough, which allegedly caused discomfort upon insertion.Additionally, the funnel design does not allow for a snug fit on the syringe, which allegedly caused the patient to lose medication.No medical intervention was reported.
 
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: "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 instruction." 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.
 
Event Description
It was reported that the catheters were not lubricated enough, which allegedly caused discomfort upon insertion.Additionally, the funnel design does not allow for a snug fit on the syringe, which allegedly caused the patient to lose medication.No medical intervention was reported.
 
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Brand Name
ROCHESTER INTERMITTENT MAGIC3 ANTIBACTERIAL PRECONNECTED TRAY 14FR 20BX
Type of Device
MAGIC 3 CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8354687
MDR Text Key137938923
Report Number1018233-2019-00892
Device Sequence Number1
Product Code OHR
UDI-Device Identifier00801741068676
UDI-Public(01)00801741068676
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number53814
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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