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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ANGEL WING 23G BCS W/LUER ADPTR; BLOOD COLLECTION SET
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COVIDIEN ANGEL WING 23G BCS W/LUER ADPTR; BLOOD COLLECTION SET Back to Search Results
Model Number 8881225307
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2014
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 reports upon removal of the butterfly from the pt's arm, the needle separated from the butterfly and was left in pt.The needle was removed from the pt and no further treatment was necessary.
 
Manufacturer Narrative
(b)(4) 2014.An investigation is currently underway.Upon completion, the results will be forwarded.
 
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Brand Name
ANGEL WING 23G BCS W/LUER ADPTR
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, MD 02048
5084524686
MDR Report Key3793208
MDR Text Key4478176
Report Number1282497-2014-00005
Device Sequence Number1
Product Code GJE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/09/2014
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 Number8881225307
Device Catalogue Number8881225307
Device Lot Number132770093X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/09/2014
Initial Date FDA Received01/15/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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