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

Catalog Number	53614G
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/23/2025
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.Udi format updated with available product information per gudid.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 patient indicated one of the catheters they received did not have any eyelets.Per patient complaint form received on (b)(6) 2025, just want to make them aware of a panic situation hey had on (b)(6) 2025.Patient have used your catheters for more than 7 years, never had a problem, never had a complaint.On saturday (b)(6) 2025, at 10:00pm, they became panic stickle when they inserted a catheter because they had an urge to urinate and nothing came out.They pulled the catheter out and reinserted it and once again nothing came out.Then they looked at the catheter, wiped off the exit end.Put it in their mouth and blew.Nothing the entrance tip was not open.They pulled out another catheter inserted it, urine flowed.After several thousand successful uses one catheter was faulty.
Additional Manufacturer Narrative
The reported event is confirmed - manufacturing related.Visual: received 1 opened magic 3 intermittent catheter.Visual inspection noted the catheter had no eyelets.Therefore, product does not meet specifications.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The labeling and instructions for use were found to be adequate.Based on the investigation results, and no additional action is required at this time.Corrections: a, d, h.Udi format updated with available product information per gudid.H11: sections 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 pt indicated one of the catheters he received did not have any eyelets.(note: this complaint was received via us mail.The pt's letter, which accompanied the return sample he sent to lms, will be attached to the complaint file once it is opened in gcs/tw).Please have a biohazard box sent to: (b)(6).Per patient complaint form received on 29may2025, just want to make you aware of a panic situation i had on (b)(6) 2025.I have used your catheters for more than 7 years, never had a problem, never had a complaint.On saturday on (b)(6) 2025 at 10:00pm, i became panic strickle when i inserted a catheter because i had an urge to urinate and nothing came out.I pulled the catheter out and reinserted it and once again nothing came out.I'm in a panic, where is the urine going.Is it flowing thought my body.Will sepsis poison my body and kill me.What shout i do.Should i all (b)(6), should i try to drive an emergency hospital, which one? i was panicky.I told myself slow down think what to do.I looked at the catheter; i wiped off the exit end.Put it in my mouth and blew.Nothing the entrance tip was not open.I pulled out another catheter inserted it, urine flowed.I sad, i'm safe, i'll live.After several thousand successful uses one catheter was faulty.I think you should be aware and decide it users should be advised and not panic as i did, i have enclosed the faulty catheter so you can evaluate what man have allowed one faulty slip thrown your system.P.S., i how blow into ach catheter before i used it.I don't need to panic again.No.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22182955
• Report Number: 1018233-2025-04371
• Device Sequence Number: 8356118
• Product Code: KOD
• UDI-Device Identifier: 00801741069772
• UDI-Public: (01)00801741069772(11)250110(17)291128(10)JUJZ0107
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/19/2025

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 Catalogue Number: 53614G
• Device Lot Number: JUJZ0107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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