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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE LUER LOCK TIP SYRINGE, PISTON

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COVIDIEN 3ML SYRINGE LUER LOCK TIP SYRINGE, PISTON Back to Search Results
Model Number 1180300777
Device Problems Material Fragmentation (1261); Missing Information (4053)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2019
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation because it was discarded 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. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported that the annotation on the syringes was peeling off and can no longer be used on the sterile field. Additional information received on 12-nov-2019 stated that both the text and the graduation marks were peeling off the syringe and transferred to the entire field and also the saline bowl and into the syringes themselves. There were missing graduation marks. It was discovered about 1. 5 hours into the case.
 
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Brand Name3ML SYRINGE LUER LOCK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
2010 east international speedw
deland FL 32724
Manufacturer (Section G)
COVIDIEN
2010 east international speedw
deland FL 32724
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key9312477
MDR Text Key166323382
Report Number1017768-2019-00732
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 11/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1180300777
Device Catalogue Number1180300777
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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