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

Model Number	53516G
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348)
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.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.The device was not returned.
Event or Problem Description
It was reported that the magic 3 catheters lacked lubrication and caused damage to the patient's urethra.It was also noted that this resulted in the patient having to use a foley catheter for approximately a week and a half.No medical intervention reported.
Additional 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 state the following: "intermittent catheter antibacterial hydrophilic coated silicone 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 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.Contains nitrofurazone french size male length (16in / 40cm) female length (6in / 15cm) 12 fr/ch 43.26 ¿ 64.43mg 20.60 ¿ 30.68mg 14 fr/ch 50.40 ¿ 74.93mg 24.00 ¿ 35.68mg 16 fr/ch 56.36 ¿ 83.92mg 26.84 ¿ 39.96mg 18 fr/ch 64.43 ¿ 95.93mg 30.68 ¿ 45.68mg 20 fr/ch 73.10 ¿ 108.75 mg 31.22 ¿ 46.45mg the silicone layer on the external surface of the catheter is impregnated with nitrofurazone.The nitrofurazone elutes into the urethral-catheter boundary producing local antibacterial 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 non-susceptible 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.References 1.Marion-landais g.Et al.Non-absorption of nitrofurazone from the urethra in men.Current therapeutic research.1976; 19: 550-3.2.Glascock hw, et al.Is nitrofurazone a primary irritant or a potent sensitizer? review of allergy.1969; 23: 54-8.Units caution: federal (usa) law restricts this device to sale by or on the order of a physician.Lot number catalog number single use.Sterilized using irradiation.Not made with natural rubber latex.Not made with pvc.Keep away from sunlight.Do not use if package is damaged.".
Event or Problem Description
It was reported that the magic 3 catheters lacked lubrication and allegedly caused damage to the patient's urethra.It was also noted that this resulted in the patient having to use a foley catheter for approximately a week and a half.No medical intervention reported.

• 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: 7468667
• Report Number: 1018233-2018-01371
• Device Sequence Number: 1215935
• Product Code: MJC
• UDI-Device Identifier: 00801741069727
• UDI-Public: (01)00801741069727
• 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: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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: 53516G
• Device Catalogue Number: 53516G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR