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

Catalog Number 53514G

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

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 patient had significant difficulty to insert the magic3 hydrophilic male intermittent catheters with bleeding, and too much friction.Some of the catheters were not lubricating properly, so patient had to withdraw them to avoid hurting and cause bleeding.Upon examination following the problem, some catheters were noticeably larger than the other catheters.Liberator replaced some which were the same and patient had found the most recent order of february 12 to be the same.Also, some catheters worked as they always had, but many had to withdraw and try to find another that will work increasing the risk of infection.The home care nurse checked to see if the problem was because of patient's prostrate or strictures but found none that it was the product.Also, patient's urologist thought that perhaps the problem arose somehow from storage before received them.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: d, h.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

Event Description

It was reported that the patient had significant difficulty to insert the magic3 hydrophilic male intermittent catheters with bleeding, and too much friction.Some of the catheters were not lubricating properly, so patient had to withdraw them to avoid hurting and cause bleeding.Upon examination following the problem, some catheters were noticeably larger than the other catheters.Liberator replaced some which were the same and patient had found the most recent order of (b)(6) to be the same.Also, some catheters worked as they always had, but many had to withdraw and try to find another that will work increasing the risk of infection.The home care nurse checked to see if the problem was because of patient's prostrate or strictures but found none that it was the product.Also, patient's urologist thought that perhaps the problem arose somehow from storage before received them.No medical intervention was reported.

Event Description

It was reported that the patient had significant difficulty to insert the magic hydrophilic male intermittent catheters with bleeding, and too much friction.Some of the catheters were not lubricating properly, so patient had to withdraw them to avoid hurting and cause bleeding.Upon examination following the problem, some catheters were noticeably larger than the other catheters.Liberator replaced some which were the same and patient had found the most recent order of february 12 to be the same.Also, some catheters worked as they always had, but many had to withdraw and try to find another that will work increasing the risk of infection.The home care nurse checked to see if the problem was because of patient's prostrate or strictures but found none that it was the product.Also, patient's urologist thought that perhaps the problem arose somehow from storage before received them.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive due to poor sample condition.Visual evaluation noted 1 opened intermittent catheter was received.As sample was received opened, lubricity was unable to be tested.Investigation is inconclusive as sample was previously opened.Although an exact root cause could not be determined, a potential root cause was mechanical failure.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: "intended use: ¿ the catheter is intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.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.¿ release the sterile water from the foil packet.¿ tip the catheter pouch end-to-end three to six times so the water moves back and forth to thoroughly wet the catheter surface.¿ peel open the pack at the funnel end just enough to expose the insertion sleeve.Don¿t remove the catheter yet.Use the adhesive tab at the funnel end of the pack to stick the pack to a nearby vertical surface while preparing to catheterize.¿ wash the area around the meatus before catheterizing.¿ wash your hands again.Hold the insertion sleeve with your dominant hand and squeeze it to grip the catheter shaft as you remove the catheter from the pack.¿ next, hold the catheter funnel above the insertion sleeve with your other hand and slide the insertion sleeve down the shaft, stopping at about 6¿ from the tip.Release the funnel.¿ using the insertion sleeve to hold the catheter firmly, gently pass the tip of the catheter into your urethra until the insertion sleeve nears the meatus.Repeat 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: MAGIC3 INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE
• Type of Device: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11486323
• MDR Text Key: 240036010
• Report Number: 1018233-2021-01288
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K033477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 53514G
• Device Lot Number: JUEV1785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR