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

Model Number	000286
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device 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 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 after some days (time unknown) of a feeding device button installment, there was an alleged leak between the button and the extensions.It was further reported that the extensions allegedly leaked for approximately four days.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot met all release criteria, this is the first complaint reported for this lot number and general issue to date.Investigation summary: one 24 fr x 2.4cm button kit was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for leaking at adaptor extensions, as leaking was observed at both large tube straight adapters and the small tube straight adapter when the sample was infused against resistance.No obvious damage was observed on the hole and adapter surfaces and no obvious abnormalities in the measured diameters were observed.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported 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.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 after some days (time unknown) of a feeding device button installment, there was an alleged leak between the button and the extensions.It was further reported that the extensions allegedly leaked for approximately four days.There was no reported patient injury.

• Brand Name: 24F X 2.4 CM BUTTON KIT
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7898853
• Report Number: 3006260740-2018-02538
• Device Sequence Number: 285063
• Product Code: KGC
• UDI-Device Identifier: 10801741087896
• UDI-Public: (01)10801741087896
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 000286
• Device Catalogue Number: 000286
• Device Lot Number: HUAT1462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1