MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. GROSHONG MID LINE MINI TRAY 4F

Catalog Number 7715435

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/16/2014

Event Type  Injury  

Event Description

They informed us that after some hours from the implant they noted that the connector detached from the catheter with the migration of the catheter at 2 cm from the skin.The catheter has been removed surgically.

Manufacturer Narrative

A lot history review (lhr) of reye1655 showed no other similar product complaint(s) from these lot numbers.The device has not been returned to the manufacturer, at this time, for evaluation.

• Brand Name: GROSHONG MID LINE MINI TRAY 4F
• Manufacturer (Section D): BARD ACCESS SYSTEMS INC.; salt lake city UT
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w; salt lake city UT 84116
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116 ; 8015224969
• MDR Report Key: 4281396
• MDR Text Key: 20750288
• Report Number: 3006260740-2014-00576
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K871080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7715435
• Device Lot Number: REYE1655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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
• Patient Age: 88 YR