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

Model Number 000282

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Skin Discoloration (2074); Swelling (2091)

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 device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of huyl1300 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the dome migrated. The patients parents were caring for the device after discharge. The device was intact but had migrated out of the patient's stomach. This was discovered due to the child complaining of pain, the presence of swelling and redness at the insertion site, and the device was no longer sitting flush against the skin; the shaft of the device was visible and usually on an angle there is an obvious lump at the site. There was no complication as a result of this event.

• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7069159
• MDR Text Key: 93460063
• Report Number: 3006260740-2017-02153
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K904779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 000282
• Device Catalogue Number: 000282
• Device Lot Number: HUYL1300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial