MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 GO PEDIATRIC CATHETER WITH SUREGRIP; MAGIC 3 CATHETER

Model Number	52808G
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Illegible Information (4050)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Burning Sensation (2146); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that wrong label was attached to the magic 3 intermittent catheter.Per follow up via email on 29-nov-2021 the customer stated that they could find the catheters of different size in the box.The biggest catheters caused the patient to experience burning and bleeding sensation during the procedure.No medical intervention was reported.Per follow up via email on 01-dec-2021 the complainant was not satisfied with the diameter of the catheter which leads to the patient to experience bleeding and burning feeling and assumed it must be a different french size than what is on the label which leads to the allegation of the labeling being wrong.The user felt that the labeling must be incorrect since the french size was not what they expected.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.Visual evaluation noted 2 photo samples of magic 3 go.First photo sample compares two catheters received in the same packaging which vary in thickness.Second photo sample received of exterior of unopened magic 3 go in original packaging win size 8 french.Dimensional evaluation noted although catheter diameter cannot be measured both catheters pictured vary in thickness.Therefore, it is unknown if the product meets specifications.Although an exact cause could not be determined a potential cause could be incorrect product identification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review was not performed because labeling could not have prevented the reported failure.Corrections: e, f, h.H11:section a through f - the information provided by bd represents all of 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that wrong label was attached to the magic 3 intermittent catheter.Per follow up via email on 29nov2021 the customer stated that they could find the catheters of different size in the box.The biggest catheters caused the patient to experience burning and bleeding sensation during the procedure.No medical intervention was reported.Per follow up via email on 01dec2021 the complainant was not satisfied with the diameter of the catheter which leads to the patient to experience bleeding and burning feeling and assumed it must be a different french size than what is on the label which leads to the allegation of the labeling being wrong.The user felt that the labeling must be incorrect since the french size was not what they expected.Per follow up via email on 03jan022, the issue occurred in 2 units from same lot number jufr2087.

• Brand Name: MAGIC3 GO PEDIATRIC CATHETER WITH SUREGRIP
• Common Device Name: MAGIC 3 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: 13003144
• Report Number: 1018233-2021-08034
• Device Sequence Number: 17322274
• Product Code: EZD
• UDI-Device Identifier: 00801741136863
• UDI-Public: (01)00801741136863
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: 52808G
• Device Catalogue Number: 52808G
• Device Lot Number: JUFR2087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 06/04/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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 Sex: Unknown