MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON GASTROSTOMY TUBE, KIT, 24F; FEEDING DEVICE

Model Number	000285
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Seizures (2063); No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned to the manufacturer for evaluation; however two electronic videos were provided and reviewed.The investigation is confirmed for leakage observed in the videos.The definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 000285 feeding device allegedly leaked.This information was received from (b)(6).One patient was involved with no reported patient injury.Age, gender and weight of the patient was not provided.
Additional Manufacturer Narrative
H10: the complaint was reassessed as si and is reported under emdr number 3006260740-2020-02873.H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned to the manufacturer for evaluation; however two electronic videos were provided and reviewed.The investigation is confirmed for leakage observed in the videos.The definitive root cause is unknown.The device is labeled for single use.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 000285 feeding device allegedly leaked.This information was received from one source.One patient was involved who experienced seizures.The age and weight of the female patient was not provided.

• Brand Name: BARD BUTTON GASTROSTOMY TUBE, KIT, 24F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10284004
• Report Number: 3006260740-2020-02469
• Device Sequence Number: 2679691
• 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): 10/15/2020

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: HUCU2440
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/15/2020
• Patient Sequence Number: 1