MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 8F 10" MAGIC3 GO PEDIATRIC CATHETER W/SURE-GRIP; MAGIC 3 GO

Model Number	52808G
Medical Device Problem Code	Break (1069)
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.The device was not returned.
Event or Problem Description
It was reported that patient said there are some catheters in every order on which the funnel is torn not completely sealed at the top of the funnel, and makes the medicine leak.
Additional Manufacturer Narrative
The reported event could not be confirmed.A potential root cause for this failure could be "no tooling specification".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿inspect the catheter before use.Do not use the product if the device or packaging is damaged.".
Event or Problem Description
It was reported that there were some catheters in every order where the funnel was torn not completely sealed at the top, which made the medicine leak.

• Brand Name: 8F 10" MAGIC3 GO PEDIATRIC CATHETER W/SURE-GRIP
• Common Device Name: MAGIC 3 GO
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9913957
• Report Number: 1018233-2020-02198
• Device Sequence Number: 2177228
• Product Code: EZD
• UDI-Device Identifier: 00801741136863
• UDI-Public: (01)00801741136863
• 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): 04/24/2020

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 Model Number: 52808G
• Device Catalogue Number: 52808G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/19/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1