MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 24F X 1.7CM BUTTON KIT; BUTTON GASTROSTOMY TUBE KITS

Model Number	000285
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 000285 button gastrostomy tube kits allegedly a leak was identified.This report was received from a single source.Of the one event, did involve patient with no reported patient injury.The patients age, weight and gender was not provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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
This report summarizes one malfunction event.A review of the event indicated that model 000285 button gastrostomy tube kits allegedly a leak was identified.This report was received from a single source.Of the one event, did involve patient with no reported patient injury.The patients age, weight and gender was not provided.

• Brand Name: 24F X 1.7CM BUTTON KIT
• Common Device Name: BUTTON GASTROSTOMY TUBE KITS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; lot #1, road #3, km 79.7; salt lake city UT 84116
• MDR Report Key: 8529671
• Report Number: 3006260740-2019-01011
• Device Sequence Number: 1870541
• Product Code: KGC
• UDI-Device Identifier: 10801741087889
• UDI-Public: (01)10801741087889
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: No Information
• Device Model Number: 000285
• Device Catalogue Number: 000285
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1