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

Model Number 53514G

Device Problem Improper Chemical Reaction (2952)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/13/2021

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 in inserting 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 some catheters were noticeably larger than the other catheters.Liberator replaced and patient had found same issue with the most recent order of (b)(6).Also, some catheters did work as they always had, but many had to be withdrawn and try to find another that will work, increasing the risk of infection.The home care nurse checked to see if the problem was because of patient's prostrate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 no evidence 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.As per the follow up on 16mar21, there was a noticeable difference in the diameter of some which user had to withdraw.However, it seems the lubricity has been the big issue (juev2250), even when user used an additional surgical lubricant, as advised by a home care nurse.The nurse also checked to see if there was a problem with an enlarged prostrate or stricture and found none.Also, there was significant bleeding, not just a little blood on the catheter, and bleeding with blood clots.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive due to poor sample condition.Visual evaluation noted one opened intermittent catheters without packaging was received.No damage noted on catheter.As the catheter was previously opened/used, no further testing was completed.Although an exact root cause could not be determined, a potential root cause is utilization of incorrect mixing checklist.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 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.".

Event Description

It was reported that the patient had significant difficulty in inserting 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 some catheters were noticeably larger than the other catheters.Liberator replaced and patient had found same issue with the most recent order of february 12.Also, some catheters did work as they always had, but many had to be withdrawn 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 no evidence 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.As per the follow up on 16mar21, there was a noticeable difference in the diameter of some which user had to withdraw.However, it seems the lubricity has been the big issue (juev2250), even when user used an additional surgical lubricant, as advised by a home care nurse.The nurse also checked to see if there was a problem with an enlarged prostrate or stricture and found none.Also, there was significant bleeding, not just a little blood on the catheter, and bleeding with blood clots.No medical intervention was reported.Per follow up on 16mar2021, there was a noticeable difference in the diameter of some which i had to withdraw.However, it seems the lubricity has been the big issue, even when they use an additional surgical lubricant, as advised by a home care nurse.The nurse also checked to see if there was a problem with an enlarged prostrate or stricture and found none.Also, there was significant bleeding, not just a little blood on the catheter, and bleeding with blood clots.

• Brand Name: MAGIC3 INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE
• Type of Device: INTERMITTENT CATHETER WITH SURE-GRIP SLEEVE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11569508
• MDR Text Key: 243952573
• Report Number: 1018233-2021-01598
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741069710
• UDI-Public: (01)00801741069710
• 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
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 53514G
• Device Catalogue Number: 53514G
• Device Lot Number: JUEV2250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR