MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM; TUBE, GASTRO-ENTEROSTOMY

Model Number	000282
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records 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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during the placement procedure the button allegedly leaked.A new button was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot met all release criteria.Investigation summary: based on the sample evaluation: one bard button replacement gastrostomy tube kit ,18fr 1.7 cm was returned for evaluation.Visual and functional evaluations were performed.The investigation is inconclusive for button valve leak, as the button device was attached to the continuous feeding adaptor found with the complaint sample and flushed with a syringe filled with water.No leaks occurred in the assembly.The assembly was then aspirated by pulling on the syringe handle.Water was held throughout the assembly and no obvious leaks with the valve were found.The button dome was removed.No visual defects were noticed.However, the clinical conditions are unknown which could have caused the button valve to leak, therefore the complaint is considered inconclusive.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review:a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that during the placement procedure the button allegedly leaked.A new button was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.
Event or Problem Description
It was reported that during the placement procedure the button allegedly leaked.A new button was used to complete the procedure.There was no reported patient injury.

• Brand Name: BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE 18F X 1.7CM
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7903787
• Report Number: 3006260740-2018-02561
• Device Sequence Number: 11189421
• Product Code: KGC
• UDI-Device Identifier: 10801741087858
• UDI-Public: (01)10801741087858
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2019

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: 000282
• Device Catalogue Number: 000282
• Device Lot Number: HUBS1188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 11/29/2018; 03/29/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 12/14/2018; 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 MO