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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MAGELLAN TB 1 ML 27X1/2 SYRINGE, PISTON

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COVIDIEN MAGELLAN TB 1 ML 27X1/2 SYRINGE, PISTON Back to Search Results
Model Number 8881882712
Device Problems Human-Device Interface Problem (2949); Fail-Safe Did Not Operate (4046)
Patient Problem Needle Stick/Puncture (2462)
Event Date 01/25/2021
Event Type  Injury  
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.   if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported that the safety device that must be pushed up the needle after administration was blocked, remaining stuck at the bottom, unable to secure the needle. When the staff wanted to re-cap the needle (which is contraindicated, she was told and well aware of this) but the needle pierced the cap and she pricked herself.
 
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Brand NameMAGELLAN TB 1 ML 27X1/2
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 Key11248051
MDR Text Key229288593
Report Number1915484-2021-01204
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
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 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881882712
Device Catalogue Number8881882712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/28/2021 Patient Sequence Number: 1
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