MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® STOMACH/INTESTINAL TUBE; TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE

Model Number	000724
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/09/2020
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 doctor tested the balloon on the tri-funnel replacement gastrostomy tube, before use.The device leaked saline during the test, the device was not used.The procedure was completed successfully with another product from the same lot number.
Additional Manufacturer Narrative
Per review, it has been determined that this product belongs to the bpv division and not bmd.Therefore, the parent record will be downgraded and closed.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.
Event or Problem Description
It was reported that the doctor tested the balloon on the tri-funnel replacement gastrostomy tube, before use.The device leaked saline during the test, the device was not used.The procedure was completed successfully with another product from the same lot number.

• Brand Name: BARD® STOMACH/INTESTINAL TUBE
• Common Device Name: TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10001911
• Report Number: 1018233-2020-02849
• Device Sequence Number: 16868227
• Product Code: KNT
• UDI-Device Identifier: 00801741037177
• UDI-Public: (01)00801741037177
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: Health Professional
• Device Model Number: 000724
• Device Catalogue Number: 000724
• Device Lot Number: NGDP2010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1