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

Model Number	52808G
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Burning Sensation (2146); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that wrong label was attached on the magic 3 intermittent catheter.Per follow up via email on 29nov2021, customer stated that they could find 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.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that wrong label was attached on the magic 3 intermittent catheter.Per follow up via email on 29nov2021, customer stated that they could find 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 01dec021, the complainant was not satisfied with the diameter of the catheter, leading to the patient experiencing bleeding and burning feeling, and assumed it must be a different french size than what is on the label, which led 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.
Additional Manufacturer Narrative
The reported event is confirmed- cause 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 whether the product meets specifications.Although an exact cause could not be determined a potential root cause could be incorrect product identification.The product was used for patient diagnostic or treatment.It is unknown whether the product caused the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labelling review is not required as it would not have prevented the reported event.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.
Event or Problem Description
It was reported that wrong label was attached on the magic 3 intermittent catheter.Per follow up via email on (b)(6) 2021, customer stated that they could find 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 (b)(6) 2021, the complainant was not satisfied with the diameter of the catheter, leading to the patient experiencing bleeding and burning feeling, and assumed it must be a different french size than what is on the label, which led 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 (b)(6)2022, the issue occurred in (b)(4) units from same lot number jufr2087.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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 GO PEDIATRIC CATHETER WITH SUREGRIP
• Common Device Name: MAGIC3 PEDIATRIC 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13093689
• Report Number: 1018233-2021-08460
• Device Sequence Number: 2098668
• 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,Followup
• Report Date (Section B): 07/06/2022

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: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 06/09/2022; 07/05/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 06/20/2022; 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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