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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.
 
Manufacturer Narrative
Section b5 has been updated to include additional information.Section h6 (health effect - impact code) has been added.
 
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.Additional information was received from the customer and it was stated that the needle was put inside the cap and then the needle pierced through the cap.After use, the safety shield was slide to the top during shield activation, but remaining stuck at the bottom, unable to secure the needle.Prior to activating the shield and during activation, needle bend was not observed.The customer further stated that as a medical intervention, the staff was given subcutaneous injection of calciparine.Serology test was performed for both the patient and the nurse and the test results were negative.There was no follow-up testing or medical treatment required.The current status of the staff is not declared.
 
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Brand Name
MAGELLAN TB 1 ML 27X1/2
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key11248051
MDR Text Key229288593
Report Number1915484-2021-01204
Device Sequence Number1
Product Code FMF
UDI-Device Identifier20884521005911
UDI-Public20884521005911
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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 No Information
Device Model Number8881882712
Device Catalogue Number8881882712
Was Device Available for Evaluation? No
Date Manufacturer Received01/25/2021
Patient Sequence Number1
Patient Outcome(s) Other;
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