MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ HYDROPHILIC INTERMITTENT CATHETER, MALE; MAGIC 3 CATHETER

Model Number	53614GS
Health Effect - Clinical Codes	Pain (1994); 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.The device was not returned.
Event or Problem Description
It was reported that some of the catheters were bent.It was later reported per additional information received from the customer contact via phone on 02 jul 2019, the catheters were folded in half inside the packaging and were still bent when they were removed.The patient reportedly experienced pain once the catheter was inserted.No medical intervention was reported.
Event or Problem Description
It was reported that some of the catheters were bent.It was later reported per additional information received from the customer contact via phone on 02jul2019, the catheters were folded in half inside the packaging and were still bent when they were removed.The patient reportedly experienced pain once the catheter was inserted.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed.Visual inspection noted 2 unopened magic 3 intermittent insertion kits.Visual evaluation noted no obvious defects.The samples were folded in "u" shape in the packaging.The samples were removed from the packaging, and both samples were bent.A potential root cause for this failure could be misassembled packaging (incorrect position of packages inside the box).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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.This is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/precautions and adverse reactions.Wash your hands thoroughly with soap and water.Prior to opening the sealed catheter pouch, apply pressure to the foil packet to release the water.Ensure all water is released from the foil packet.Wet the catheter by holding the package with the printed side up and tip the 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.Peel open the pack at the funnel end to expose approximately 4¿ of the catheter.Don¿t remove the catheter yet.Use the adhesive tab at the funnel end of the pack to stick the pack to a nearby dry vertical surface while preparing to catheterize.Wash the area around the meatus before catheterizing.Wash your hands again.Using the catheter with sure-grip¿ sleeve: 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.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.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: hold the funnel end and remove the catheter from the packaging.Gently pass the tip of the catheter into your urethra and advance the catheter until urine starts to flow.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.Finish by disposing of the catheter and its packaging.Wash your hands with soap and water." h11: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 or Problem Description
It was reported that some of the catheters were bent.It was later reported per additional information received from the customer contact via phone on 02jul2019, the catheters were folded in half inside the packaging and were still bent when they were removed.The patient reportedly experienced pain once the catheter was inserted.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed.Visual inspection noted 2 unopened magic 3 intermittent insertion kits.Visual evaluation noted no obvious defects.The samples were folded in "u" shape in the packaging.The samples were removed from the packaging, and both samples were bent.A potential root cause for this failure could be misassembled packaging (incorrect position of packages inside the box).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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.This is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/precautions and adverse reactions.1.Wash your hands thoroughly with soap and water.2.Prior to opening the sealed catheter pouch, apply pressure to the foil packet to release the water.Ensure all water is released from the foil packet.3.Wet the catheter by holding the package with the printed side up and tip the 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.4.Peel open the pack at the funnel end to expose approximately 4¿ of the catheter.Don¿t remove the catheter yet.Use the adhesive tab at the funnel end of the pack to stick the pack to a nearby dry vertical surface while preparing to catheterize.5.Wash the area around the meatus before catheterizing.6.Wash your hands again.7.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.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.Hold the funnel end and remove the catheter from the packaging.B.Gently pass the tip of the catheter into your urethra and advance the catheter until urine starts to flow.8.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.9.Finish by disposing of the catheter and its packaging.Wash your hands with soap and water." correction: h6.H11: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.

• Brand Name: MAGIC3¿ HYDROPHILIC INTERMITTENT CATHETER, MALE
• Common Device Name: MAGIC 3 CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8776179
• Report Number: 1018233-2019-03795
• Device Sequence Number: 1999623
• Product Code: OHR
• UDI-Device Identifier: 00801741072659
• UDI-Public: (01)00801741072659
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 08/26/2019

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 Expiration Date: 10/28/2020
• Device Model Number: 53614GS
• Device Catalogue Number: 53614GS
• Device Lot Number: JUCY0277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/16/2019; 08/21/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/21/2019; 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1