MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BUTTON 18F; BUTTONS/WIZARD

Catalog Number 000282

Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

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.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that in (b)(6) 2017, a bard button was inserted in the patient to change his/her existing gastronomy feeding tube.The day after the insertion, the patient returned due to an alleged leak from the central hole.Reportedly the leak was observed from the central hole post feeding of milk.It was reported that the stopper did not fit properly.No reported harm to patient.

Manufacturer Narrative

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.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak from the button feeding tube was inconclusive due to the sample condition.One photograph was the only item provided for investigation.What appears to be the external bolster and strap of a bard button device was shown.The button device was shown in the stoma of a patient.The strap and plug were not closed.Instead, what appears to be the 90-degree white plastic part of the feeding tube was in the button device.An arrow pointing to the 90-degree adaptor is labeled with the text, ¿temporary stopper created by us and have been used for the past 1 month.¿ an arrow pointing to the button strap and plug is labeled with the text, ¿leaking from the hold due to stopper doesn¿t fit properly ? hole too big ?stopper too small¿.The inner diameter (id) of the hole in the button device and the outside diameter (od) of the plug could not be measured since the physical sample was not returned for investigation.The complaint was therefore inconclusive.

Event Description

It was reported that in (b)(6) 2017, a bard button was inserted in the patient to change his/her existing gastronomy feeding tube.The day after the insertion, the patient returned due to an alleged leak from the central hole.Reportedly the leak was observed from the central hole post feeding of milk.It was reported that the stopper did not fit properly.No reported harm to patient.

• Brand Name: BUTTON 18F
• Type of Device: BUTTONS/WIZARD
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: michael new ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225445
• MDR Report Key: 6508348
• MDR Text Key: 73509462
• Report Number: 3006260740-2017-00491
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10801741087858
• UDI-Public: (01)10801741087858
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K904779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1