MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 INTERMITTENT CATHETER; CATHETER SILICONE INTERMITTENT 8FR PED

Model Number	52308
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
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 device was not returned.
Event or Problem Description
It was reported that the foley catheter began to leak urine from the base of the y- site.The foley was replaced with another 8fr bard catheter and noticed urine leak from the exact same spot.The customer also stated that both the catheters had a hole in the same spot.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "poor interface between the catheter shaft and the drainage funnel/handle." the lot number was 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.Warnings: this is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.How to prepare and use your urinary catheter 1.Wash your hands thoroughly with soap and water.2.Peel open the pack at the funnel end to expose approximately 2¿- 4¿ of the catheter.Don¿t remove the catheter yet.3.Wash the area around the meatus before catheterizing.4.Wash your hands again.5.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.Using the sure-grip¿ sleeve to hold the catheter firmly, lubricate catheter tip with lubricating gel.D.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.Remove the catheter from the pack.B.Lubricate the catheter tip with lubricating gel.C.Gently pass the tip of the catheter into your urethra and advance the catheter until urine starts to flow.6.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.7.Finish by disposing of the catheter and its packaging.8.Wash your hands with soap and water.".
Event or Problem Description
It was reported that the foley catheter began to leak urine from the base of the y- site.The foley was replaced with another 8fr bard catheter and noticed urine leak from the exact same spot.The customer also stated that both the catheters had a hole in the same spot.

• Brand Name: MAGIC3 INTERMITTENT CATHETER
• Common Device Name: CATHETER SILICONE INTERMITTENT 8FR PED
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10194784
• Report Number: 1018233-2020-04097
• Device Sequence Number: 19356586
• Product Code: KOD
• UDI-Device Identifier: 00801741068348
• UDI-Public: (01)00801741068348
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 52308
• Device Catalogue Number: 52308
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1