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

Catalog Number	51612
Medical Device Problem Codes	Incorrect Measurement (1383); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
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.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 catheter syringe opening was too wide spilling out the medicine that they inserts into patient bladder.They had 80 unused and 10 that they used in an attempt to make them work.Per clarification mail received from liberator on 09jul2024, it was reported that patient was having issues with the catheters with a use by date of 28dec.Stated that customer not only drain out, but always used the opening of the catheter to inject medicine.Customer said however the opening on this order the opening on the catheter was bigger.Customer had 80 unused and 10 that they used in an attempt to make them work.
Event or Problem Description
It was reported that the intermittent catheter syringe opening was too wide spilling out the medicine that they inserts into patient bladder.They had 80 unused and 10 that they used in an attempt to make them work.Per clarification mail received from liberator on 09jul2024, it was reported that patient was having issues with the catheters with a use by date of 28dec.Stated that customer not only drain out, but always used the opening of the catheter to inject medicine.Customer said however the opening on this order the opening on the catheter was bigger.Customer had 80 unused and 10 that they used in an attempt to make them work.Per customer on 15jul2024, they confirmed all the details of the reported product.Customer confirmed pcn#51612, lot jujn9214, use by date 2028dec.Customer stated that the issue was that the syringe opening was too wide, which made the medicine spill out while trying to administer it to the patient.Customer recommended a smaller opening for the syringe would be more useful.
Additional Manufacturer Narrative
Per investigator evaluation, bd has determined that this mdr as not reportable as the reported event was confirmed as user related.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
• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19710733
• Report Number: 1018233-2024-04131
• Device Sequence Number: 8604450
• Product Code: KOD
• UDI-Device Identifier: 00801741068232
• UDI-Public: (01)00801741068232(11)240123(17)281228(10)JUJN9214
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/30/2024

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: 51612
• Device Lot Number: JUJN9214
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 10/04/2024
• 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