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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 Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/10/2020
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event Description
Customer reports: there are hairline cracks in the syringe.
 
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Brand Name
3ML SYRINGE LUER LOCK TIP
Type of Device
SYRINGE, 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 Key10532187
MDR Text Key206975346
Report Number1017768-2020-00860
Device Sequence Number1
Product Code FMF
UDI-Device Identifier10884521012301
UDI-Public10884521012301
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 09/14/2020
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 Number1180300777
Device Catalogue Number1180300777
Device Lot Number013228
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/11/2020
Initial Date FDA Received09/14/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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