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

Catalog Number	51812
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that middle of center piece when use of intermittent catheter separated.This has caused more urinary tract infection (utis) for months, difficult to cure due to newfound bacteria.It was unknown what medical intervention was reported for urinary tract infection.Per follow up via phone 31july2023, customer would like to spoke to a supervisor in regard to urinary tract infection (utis).Customer was experienced while using product 51812 after the recall.The catheters were purchased from 180 medical supply.Representative advised customer to contact distributor for information and forwarded to supervision for follow up.Per follow up via phone on 31july2023, the customer has requested an escalation of this issue regarding the magic3go recall.Customer stated that they were informed of the issue on july 10th, through email, from 1800 medical and informing that they would not be using the product, but they have been using them for 2 or 2 ½ months after using them.Customer was under the impression that it was designed different.It usually came apart in one piece but now it was coming apart in 2/3 pieces.1-800 medical knew there was a problem but did not say anything to them.Customer was using 3 times a day but was now going down to 1 time a day based on that.They offered them a refund, but the issues were with the delay of giving them the information of the incident.Customer has already changed their company and ordering from arrow flow now and there they knew about an issue with the factory but was unaware of the recall.Customer stated that¿s they had uti¿s and have been stopped with the regular antibiotics but this time they had to so sipro and that stopped it also stopped using the catheters at the same time.It was bacteria that they never had before.Customer was unable to go out or do anything, their retention numbers have never been this high.Customer really like the product and they sold them the product and never told them about the issue.Customer has disclosed all this information to them but never offered customer anything.Patient was asking more information and would like to handle it before speaking with an attorney.Per follow up via phone on 02oct2023 it was reported that customer refused to return the samples until they know what the usda was saying regarding the catheters.Inquired about legal compensation.The customer was hospitalized for a week due to urinary tract infection uti's and was hooked up to an iv.The customer had recurrent uti's.They purchased the catheters from 180 medical and reported that they were not wanting a refund or replacement.
Event or Problem Description
It was reported that middle of center piece when use of intermittent catheter separated.This has caused more urinary tract infection (utis) for months, difficult to cure due to newfound bacteria.It was unknown what medical intervention was reported for urinary tract infection.Per follow up via phone 31july2023, customer would like to spoke to a supervisor in regard to urinary tract infection (utis).Customer was experienced while using product 51812 after the recall.The catheters were purchased from 180 medical supply.Representative advised customer to contact distributor for information and forwarded to supervision for follow up.Per follow up via phone on 31july2023, customer stated that they were informed of the issue on july 10th, through email, from 1800 medical and informing that they would not be using the product, but they have been using them for 2 or 2 ½ months after using them.Customer was under the impression that it was designed different.It usually came apart in one piece but now it was coming apart in 2/3 pieces.1-800 medical knew there was a problem but did not say anything to them.Customer was using 3 times a day but was now going down to 1 time a day based on that.Customer stated that¿s they had uti¿s and have been stopped with the regular antibiotics but this time they had to so sipro and that stopped it also stopped using the catheters at the same time.It was bacteria that they never had before.Customer was unable to go out or do anything, their retention numbers have never been this high.Customer really like the product and they sold them the product and never told them about the issue.Patient was asking more information and would like to handle it before speaking with an attorney.Per follow up via phone on 02oct2023, customer was hospitalized for a week due to urinary tract infection uti's and was hooked up to an iv.The customer had recurrent uti's.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "patient sensitivity to materials".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: ¿indications for use: the magic3 go¿ intermittent urinary catheter is intended for urological use only.It is intended for use by adult female patients for bladder management including urine drainage, collection, and measurement.The device is passed to the urinary bladder via the urethra.Contraindications: none known.Warnings: this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Precautions: inspect the catheter before use.Do not use the product if the device or packaging is damaged.Adverse reactions: urinary tract infection; bleeding from the urethra; irritation of the urethra.Review the self-catheterization procedure with a healthcare professional.Always wash hands prior to use.Open the catheter package by peeling the tab upwards with the aid of the finger hole.If desired, hang the package with the adhesive surface on the inner side of the tab to a nearby dry vertical surface while preparing to catheterize.Positioned comfortably with thighs spread apart, clean the opening to the urethra ¿ and the surrounding area.Wipe from front to back to avoid fecal contamination.Wash your hands again.Remove the catheter with the aid of the insertion handle and advance the catheter tip into the urethra.Slowly and gently insert the catheter into the urethra until urine begins to flow (approximately 1-1.5" or 2.5-3.8 cm).When urine stops flowing, begin to withdraw the catheter.It is recommended to slowly rotate the catheter during withdrawal, stopping each time urine begins to flow.Check the color, odor and clarity of the urine.Any changes may need to be reported to a health care professional.Disposal: place the catheter back into the package and dispose in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Do not flush down the toilet.Wash hands.¿ 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.

• Brand Name: MAGIC3 GO¿ INTERMITTENT URINARY 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18038194
• Report Number: 1018233-2023-07727
• Device Sequence Number: 20690198
• Product Code: EZD
• UDI-Device Identifier: 00801741097874
• UDI-Public: (01)00801741097874
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150345
• 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): 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2025
• Device Catalogue Number: 51812
• Device Lot Number: JUGU0870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown