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

Catalog Number	51612
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone number(s): (b)(6).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 some catheters were shorter in length compared to others, despite originating from the same batch.This discrepancy was initially identified in the first batch that was sent to a patient and, unfortunately, it was observed again in the replacement batch that was subsequently provided.The patient reported that, in some cases, the catheter did not reach the bladder, resulting in inadequate urine drainage.Batch numbers jukq0693 and jukr9153.It was informed on 22jan2026 regarding batch jukr9153, after which 56 units were returned to us.The materials remain at our facilities.For the other batch that we sent as a replacement, the products have not yet been returned.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• 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: 24533327
• Report Number: 1018233-2026-01548
• Device Sequence Number: 18366432
• Product Code: KOD
• UDI-Device Identifier: 00801741068232
• UDI-Public: (01)00801741068232(17)300328(10)JUKQ0693
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: Health Professional
• Device Catalogue Number: 51612
• Device Lot Number: JUKQ0693
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female