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

Model Number	51610
Medical Device Problem Codes	Improper Chemical Reaction (2952); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Skin Discoloration (2074); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	10/25/2021
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.
Event or Problem Description
It was reported that the intermittent catheters were hard to open and the patient had to use scissors.The patient also said that the lubrication was causing irritation, a burning sensation and redness on the urethral opening.Per email from cardinal health on (b)(6) 2021, it was stated that the packaging of intermittent catheter was difficulty to open and were causing irritation, burning and redness on the urethral opening and labia.Also stated that the patient would be scheduling an appointment with the doctor.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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 the intermittent catheters were hard to open, and the patient had to use scissors.The patient also said that the lubrication was causing irritation, a burning sensation and redness on the urethral opening.Per email from cardinal health on 27oct2021, it was stated that the packaging of intermittent catheter was difficulty to open and were causing irritation, burning and redness on the urethral opening and labia.Also stated that the patient would be scheduling an appointment with the doctor per form received with return sample on (b)(6) 2021, it was stated that patient experienced skin irritation to lamina/urethra and patient stopped using.No medical intervention was reported.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12823631
• Report Number: 1018233-2021-07290
• Device Sequence Number: 4787727
• Product Code: KOD
• UDI-Device Identifier: 00801741068225
• UDI-Public: (01)00801741068225
• 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): 03/10/2022

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 Expiration Date: 04/28/2026
• Device Model Number: 51610
• Device Catalogue Number: 51610
• Device Lot Number: JUFR0470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Race: White