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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
Medical Device Problem Code Fail-Safe Problem (2936)
Health Effect - Clinical Code Needle Stick/Puncture (2462)
Date of Event 11/09/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The customer reported after administration of heparin subcutaneous, the nurse closed the safety shield using the thumb method.The rn was aware the shield engaged, but the shield disengaged, came back exposing the needle, and the nurse was stuck.The nurse reported to employee health and needle stick protocol was followed.The site of the needle stick was cleaned and labs were obtained on the patient.All the patients tests were negative and no follow up is scheduled for the nurse at this time.
 
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Brand Name
MAGELLAN TB 1 ML 27X1/2
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key10851823
Report Number1915484-2020-01198
Device Sequence Number3490076
Product Code FMF
UDI-Device Identifier20884521005911
UDI-Public20884521005911
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number8881882712
Device Catalogue Number8881882712
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/09/2020
Initial Report FDA Received Date11/17/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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