MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 24F X 2.4 CM BUTTON KIT; FEEDING TUBE

Model Number	000286
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, a manufacturing review will 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 device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 000286 feeding tube allegedly experienced leak / splash.It was further reported that another device was used to complete the procedure.This report was received from a single source.This event did involve patient with no reported patient injury.The patient is (b)(6) years old, female; however, weight was not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation of the device did not identify a leak.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: h6(methods, results, conclusion) 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.A review of the reported information indicated that model 000286 feeding tube allegedly experienced leak / splash.It was further reported that another device was used to complete the procedure.This report was received from a single source.This event did involve patient with no reported patient injury.The patient is 3 year old, female; however, weight was not provided.

• Brand Name: 24F X 2.4 CM BUTTON KIT
• Common Device Name: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9587239
• Report Number: 3006260740-2020-00068
• Device Sequence Number: 3461432
• Product Code: KGC
• UDI-Device Identifier: 10801741087896
• UDI-Public: (01)10801741087896
• 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): 03/25/2020

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: 000286
• Device Catalogue Number: 000286
• Device Lot Number: HUBY0562
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/25/2020
• Patient Sequence Number: 1