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

Model Number	53616
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
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 intermittent catheters were sticky and not lubricated enough compared to prior order of catheters.Per follow up via phone on 19-oct-2022, customer stated that there was not enough lubricant and also stated that customer was able to use the product with extra lubricant added.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "operator error".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported 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: "instructions for use 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.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.Warning: this is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.Urethral catheter for urological use only.Discard after use, do not resterilize.Made of silicone elastomer." the device was not returned.
Event or Problem Description
It was reported that the intermittent catheters were sticky and not lubricated enough compared to prior order of catheters.Per follow up via phone on 19-oct-2022, customer stated that there was not enough lubricant and also stated that customer was able to use the product with extra lubricant added.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15675087
• Report Number: 1018233-2022-08128
• Device Sequence Number: 6462861
• Product Code: KOD
• UDI-Device Identifier: 00801741068584
• UDI-Public: (01)00801741068584
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: 53616
• Device Catalogue Number: 53616
• Device Lot Number: JUGQ3857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male