MONOJECT SYRINGE, 3 CC LUER SLIP 8881513918 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-13 for MONOJECT SYRINGE, 3 CC LUER SLIP 8881513918 * manufactured by Kendall.

Event Text Entries

[616703] Emergency department nurse was using monoject 3ml luer slip syringe to draw blood from patient's peripheral iv. Once blood was obtained the nurse then used the syringe to push the blood into a culture bottle. As the blood was being pushed into bottle, the tip of the syringe cracked and blood sprayed from syringe. The syringe was retained by risk management.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number844465
MDR Report Key844465
Date Received2007-04-13
Date of Report2007-04-09
Date of Event2007-03-01
Report Date2007-04-09
Date Reported to FDA2007-04-13
Date Added to Maude2007-05-07
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameMONOJECT SYRINGE, 3 CC LUER SLIP
Generic NameSYRINGE
Product CodeFMF
Date Received2007-04-13
Model Number8881513918
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key831652
ManufacturerKENDALL
Manufacturer AddressA DIVISION OF TYCO HEALTHCARE 15 HAMPSHIRE STREET MANSFIELD MA 02048 US

Device Sequence Number: 2

Brand Name*
Generic NameCULTURE TUBE
Product CodeJSH
Date Received2007-04-13
Model Number*
Catalog Number*
Lot Number*
ID Number*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key831653
Manufacturer*
Manufacturer Address* * *

Patients

Patient NumberTreatmentOutcomeDate
10 2007-04-13
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