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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 1ML BBL SHORT REG WOS UPT 3622 SYRINGE, PISTON

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COVIDIEN 1ML BBL SHORT REG WOS UPT 3622 SYRINGE, PISTON Back to Search Results
Model Number 5551771010
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2020
Event Type  malfunction  
Manufacturer Narrative
An investigation is currently underway. Upon completion, the results will be forwarded.
 
Event Description
The customer reported that there was excess plastic/flash on the luer nibs causing fitting issues when the tubes are fitted into fixtures. The excess comes away during application.
 
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Brand Name1ML BBL SHORT REG WOS UPT 3622
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer (Section G)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key10392887
MDR Text Key202442683
Report Number1915484-2020-01180
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5551771010
Device Catalogue Number5551771010
Device Lot Number015335X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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