MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BUTTON GASTROSTOMY FEEDING TUBE; FEEDING DEVICE

Model Number	000287
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.A photo of the device was provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that the button connections on the feeding tube were allegedly loose.It was further reported that medication administered through the feeding tube, would leak through the probe.The patient was not able to report any injury.
Event or Problem Description
It was reported that the button connections on the feeding tube were allegedly loose.It was further reported that medication administered through the feeding tube, would leak through the probe.The patient was not able to report any injury.
Additional Manufacturer Narrative
Per the lot history review, this is the first complaint reported for this lot number and issue to date.The quantity affected is 1.Based upon the severity level and lot quantity, a dhr review is not required.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.Investigation summary: one bard button replacement gastrostomy tube, 24fr, 3.4 cm was returned for evaluation.Visual, functional as well as dimensional evaluations were performed.Comparing the dimensions measured with the corresponding drawings led to the conclusion that dimensions don¿t present any obvious problems with a loose connection.The investigation is confirmed for leak at tube connection(s), as mild leaking was observed during infusion of the 90 degree adapter.It is unclear if the 90 degree adapter was being used in the video submitted.However, leaking can be seen at the connection, which further confirms the conclusion of the functional testing.The definitive root cause could not be determined based upon available information.It is unknown if clinical/manufacturing/shipping procedures issues contributed to the reported event.(expiration date: 02/2021).
Additional Manufacturer Narrative
Manufacturing review: a dhr review is not required, however it was requested.The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one bard button replacement gastrostomy tube, 24fr, 3.4 cm was returned for evaluation.Functional, dimensional as well as visual evaluations were performed.The investigation is confirmed for damaged/defective accessory, as three distinctive bends were observed along the length of the wire and sheath and some stress whitening was observed on the outer sheath near the bends.The definitive root cause could not be determined based upon available information.It is unknown if clinical/manufacturing/shipping procedures 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 the button connections on the feeding tube were allegedly loose.It was further reported that medication administered through the feeding tube, would leak through the probe.The patient was not able to report any injury.

• Brand Name: BUTTON GASTROSTOMY FEEDING TUBE
• Common Device Name: FEEDING DEVICE
• 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: 8227580
• Report Number: 3006260740-2018-03834
• Device Sequence Number: 16634400
• Product Code: KGC
• UDI-Device Identifier: 10801741087902
• UDI-Public: (01)10801741087902
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K904779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2019

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: 000287
• Device Catalogue Number: 000287
• Device Lot Number: HUCQ0333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 03/11/2019; 05/24/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 03/25/2019; 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 80