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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
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event 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
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
Manufacturer (Section G)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX   22500
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key11300463
MDR Text Key230932968
Report Number9612030-2021-02795
Device Sequence Number1
Product Code FMF
UDI-Device Identifier10884521010970
UDI-Public10884521010970
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 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
Device Operator No Information
Device Model Number8881512258
Device Catalogue Number8881512258
Device Lot Number2023835164
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/01/2021
Initial Date FDA Received02/09/2021
Type of Device Usage N
Patient Sequence Number1
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