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

Catalog Number	53616G
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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 customer had a defective intermittent catheter due to the adhesive missing.They were able to get replacement product sent, however the replacement product also was missing the adhesive.
Event or Problem Description
It was reported that customer had a defective intermittent catheter due to the adhesive missing.They were able to get replacement product sent, however the replacement product also was missing the adhesive.
Additional Manufacturer Narrative
The reported event is unconfirmed- product met specifications.No root cause could be found because the reported event was unconfirmed.Photo: received two (2) photo samples.Both photo samples showcase four (4) unopened iscs.One (1) isc had double sided tape, the other two (2) iscs did not have double sided tape, and the fourth isc unable to determine.Based on the photo samples received and the waiver issuance 03-2024-022, the product meets specifications.A review of the device history record was not necessary due to the reported event being unconfirmed.A labeling review is not required.Correction: d, e, h.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.

• 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 30014 ; 7707846100
• MDR Report Key: 20683371
• Report Number: 1018233-2024-07194
• Device Sequence Number: 12559669
• Product Code: KOD
• UDI-Device Identifier: 00801741069789
• UDI-Public: (01)00801741069789(11)240623(17)290528(10)JUJS1246
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 53616G
• Device Lot Number: JUJS1246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2024
• 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