MAUDE Adverse Event Report: COVIDIEN ANGEL WING 23G BCS W/ LUER ADPTR; BLOOD COLLECTION SET

Model Number 8881225307

Device Problems Device Operates Differently Than Expected (2913); Reset Problem (3019)

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

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a blood collection set.The customer reports the safety cover did not activate as expected.When pulling back the wings the cover does not activate.

Manufacturer Narrative

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

• Brand Name: ANGEL WING 23G BCS W/ LUER ADPTR
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes li; 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: 4120816
• MDR Text Key: 17292570
• Report Number: 1282497-2014-00044
• Device Sequence Number: 1
• Product Code: GJE
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2014

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: 140450242X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 07/28/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1