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	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient who was disabled had been using bd brand of catheters for more than 5 years.It was reported in late april 2023, that the manufacturer bard was halting production due to material shortages and production issues and asked to temporarily use a different manufactures product.However, they still had ample supply of the magic3 go intermittent silicone catheter and continued to use the overflow of catheters.On 01aug2023, they received via email a recall notice from supplier.They would like to know how long bard knew about the possible contamination and when the suppliers of recalled product (magic3 go intermittent silicone catheter) were notified.Also stated that 50 boxes of product were contaminated.As per follow up via phone on 10aug2023, there was no allegation against the device.The customer was wanting information on the recall.As per follow up information received on (b)(6) 2023, customer experienced urinary tract infection over the last year or more.Three lot numbers were provided (jugt0319 ), (jugp2374), (jufy9030).
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 patient who was disabled had been using bd brand of catheters for more than 5 years.It was reported in late (b)(6) 2023, that the manufacturer bard was halting production due to material shortages and production issues and asked to temporarily use a different manufactures product.However, they still had ample supply of the magic3 go intermittent silicone catheter and continued to use the overflow of catheters.On (b)(6) 2023, they received via email a recall notice from supplier.They would like to know how long bard knew about the possible contamination and when the suppliers of recalled product (magic3 go intermittent silicone catheter) were notified.Also stated that 50 boxes of product were contaminated.As per follow up via phone on (b)(6)2023, there was no allegation against the device.The customer was wanting information on the recall.As per follow up information received on (b)(6) 2023, customer experienced urinary tract infection over the last year or more.Three lot numbers were provided (jugt0319), (jugp2374), (jufy9030).
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".It was unknown whether the device had met relevant specifications.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 states 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.1.Always wash hands prior to use.2.Open the catheter package by peeling the tab upwards with the aid of the finger hole.3.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.4.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.5.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).6.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 7.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.8.Wash hands.¿ correction- 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.

• 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: 17611432
• Report Number: 1018233-2023-06273
• Device Sequence Number: 7552145
• Product Code: EZD
• UDI-Device Identifier: 00801741097874
• UDI-Public: (01)00801741097874
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/11/2023

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: 02/28/2025
• Device Catalogue Number: 51812
• Device Lot Number: JUGP2374
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2022
• 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: Unknown