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

Model Number	52806G
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
It was reported that the packages were marked with 6fr, but the catheter inside was 8fr.
Event or Problem Description
It was reported that the packages were marked with 6fr, but the catheter inside was 8fr.
Additional Manufacturer Narrative
The reported event was inconclusive, due to the poor sample condition.Visual inspection noted that two photo samples were received.The first photo shows the individual package labels for two 6fr magic 3 go catheters.The second photo shows the tips of the two catheters side by side.Without the physical sample, it was unable to be determine whether the outer diameter of the catheter meets the specifications, therefore the results of the investigation were inconclusive due to the poor sample condition.A potential root cause for this failure mode could be due to an operator error.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.It was unknown whether the device had met specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed due to the labelling could not have prevented the reported failure.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.

• Brand Name: MAGIC3 GO PEDIATRIC CATHETER WITH SUREGRIP
• Common Device Name: MAGIC3 GO PEDIATRIC CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10573430
• Report Number: 1018233-2020-06152
• Device Sequence Number: 3830525
• Product Code: EZD
• UDI-Device Identifier: 00801741136856
• UDI-Public: (01)00801741136856
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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 Expiration Date: 08/25/2021
• Device Model Number: 52806G
• Device Catalogue Number: 52806G
• Device Lot Number: JUCV0334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1