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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP SYRINGE, PISTON

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COVIDIEN 60ML SYRINGE LUER LOCK TIP SYRINGE, PISTON Back to Search Results
Model Number 1186000777
Device Problems Fluid Leak (1250); Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2020
Event Type  malfunction  
Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
 
Event Description
The customer reported that shortly after change of shift, it was noted that the lipids line was wet. Tracing back up to the spot where the syringe was screwed into the line's hub there was a large amount of leakage. The end of the syringe was broken. Lipids were stopped and disconnected from the patient and the nurse practitioner was made aware. The pharmacy was contacted and they stated that it was all prepared under a hood to maintain sterility so the whole set up (tpn, total parenteral nutrition, included) would need to be redone. The nurse practitioner was made aware and stated that the patient could go without lipids for the night. Additional information was received from the customer stated that there was no impact to the patient and no intervention needed for the patient other than replacing the medication.
 
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Brand Name60ML SYRINGE LUER LOCK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer (Section G)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key11412773
MDR Text Key234719933
Report Number1915484-2021-01214
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1186000777
Device Catalogue Number1186000777
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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