MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC MYPICC* KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number CK000199

Device Problems Retraction Problem (1536); Defective Device (2588); Fail-Safe Problem (2936); Mechanics Altered (2984)

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

Event Date 06/20/2016

Event Type  malfunction  

Event Description

The staff using this device have found that the safety lock that should end over the tip of the device is staying at the hub during retraction, which is resulting in an exposed needle tip.Staff has found a total of 6 defective locks.This issue has not resulted in injury to staff or patients to date.Staff has been notified of the potential defect and has been asked to take extra precaution when using the device.4 of the 6 devices that did not work properly were all from the same lot.The sterile packaging for the other 2 lots were discarded such that a lot number could not be determined.

• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 5808156
• MDR Text Key: 49963490
• Report Number: 5808156
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: CK000199
• Device Lot Number: 16OB6835
• Other Device ID Number: SIZE 21G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1