MAUDE Adverse Event Report: COVIDIEN ANG WNG 23G BCS W/LUER ATR X50; BLOOD COLLECTION SET

Model Number 8881225307

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Connection Problem (2900); Fail-Safe Problem (2936)

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

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a blood collection set.The customer states that during a blood draw, blood started to leak from the needle and tubing connection where the butterfly safety shield is located.At the end of the blood draw, the needle disconnected from tubing.The needle, where the leak occurred, detached from the tubing as the clinician was pulling it out of the pt's arm.The needle was sticking half way into the pt's arm and half out.It was sticking out enough that the clinician could pull it out of the pt's arm without incident.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

• Brand Name: ANG WNG 23G BCS W/LUER ATR X50
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): COVIDIEN; 37 blvd insurgentes libriamento; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 37 blvd insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer Contact: elaine bishop ; 15 hampshire st.; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 4010054
• MDR Text Key: 4951868
• Report Number: 1282497-2014-00043
• Device Sequence Number: 1
• Product Code: GJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/23/2014

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
• Device Operator: Health Professional
• Device Model Number: 8881225307
• Device Catalogue Number: 8881225307
• Device Lot Number: 132490198X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 07/18/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1