MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE; MAGIC 3 CATHETER

Model Number	53512G
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the burst packets did not have enough solution to lubricate the catheters.
Event or Problem Description
It was reported that the burst packets did not have enough solution to lubricate the catheters.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential failure mode could be "unable to activate coating" with a potential root cause of "insufficient water volume to cover catheter".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: "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.The silicone layer on the outer surface of the catheter is impregnated with nitrofurazone.The nitrofurazone elutes into the urethral-catheter boundary producing local anti-microbial activity.Nitrofurazone is not significantly absorbed through the urethra for the period of 12-24 hours.1 warning catheter reuse: this is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infection.Contraindication do not use in individuals with known sensitivity to nitrofurazone.Precautions general: use of certain antimicrobial agents may allow overgrowth of nonsusceptible organisms including yeast and fungi.If this occurs, or if irritation, sensitization or superinfection develops, discontinue use and institute appropriate therapy.Pediatric use: safety and effectiveness in children has not been established.Pregnancy: pregnancy category c: nitrofurazone has been shown to have an embryocidal effect in rabbits when given in oral doses thirty times the human dose.There are no adequate and well controlled studies in pregnant women.Nursing mothers: it is not known if this drug is excreted in human milk and because of the potential for tumorigenicity shown for nitrofurazone in animal studies, a decision should be made whether to discontinue nursing or to discontinue use of the catheter.Adverse reactions sensitization and generalized allergic skin reaction are known to occur in 1.2% of patients treated with topically administered nitrofurazone.Allergic reaction should be treated symptomatically.2 carcinogenesis, mutagenesis and impairment of fertility nitrofurazone has been shown to produce mammary tumors when fed in high doses to female sprague-dawley rats.The relevance of this to topical use in humans is unknown.Dietary dosage levels of 60 and 30 mg/kg/day shortened the onset time of the typical mammary gland tumors associated with older female rats.These tumors exhibited the same histological characteristics seen in the spontaneously occurring tumors, and were seen only in the female rats.No mammary tumors were seen in rats treated with nitrofurazone orally in the diet for 1 year at levels of approximately 11 mg/ kg/day.Spermatogenic arrest was noted in the male rats in dietary dosages of 30 mg/kg/day and above, after one year on test.".

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE
• Common Device Name: MAGIC 3 CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8727922
• Report Number: 1018233-2019-03313
• Device Sequence Number: 2573314
• Product Code: MJC
• UDI-Device Identifier: 00801741069703
• UDI-Public: (01)00801741069703
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 53512G
• Device Catalogue Number: 53512G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1