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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 Difficult to Advance (2920)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.   as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.   if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
Customer reports: the plunger on some of the syringes are sticking.
 
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Brand Name12ML LUER LOCK TIP PHARM TRAY
Type of DeviceSYRINGE, 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 Key11727384
MDR Text Key249684793
Report Number9612030-2021-02875
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 04/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881512258
Device Catalogue Number8881512258
Device Lot Number2030104764
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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