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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON
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COVIDIEN 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON Back to Search Results
Model Number 8881512258
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/28/2021
Type of Reportable Event Malfunction
Additional 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event or Problem Description
The customer reported they have multiple syringes that are leaking between the barrel and the plunger.Sometimes the leaking starts as soon as they start to fill them.They are filled with a baxter repeater pump on a medium speed using tubing and a luer lock assembly.
 
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Brand Name
12ML LUER LOCK TIP PHARM TRAY
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key11300463
Report Number9612030-2021-02795
Device Sequence Number17383381
Product Code FMF
UDI-Device Identifier10884521010970
UDI-Public10884521010970
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/09/2021
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
Operator of Device No Information
Device Model Number8881512258
Device Catalogue Number8881512258
Device Lot Number2023835164
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/01/2021
Initial Report FDA Received Date02/09/2021
Patient Sequence Number1
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