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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MAGELLAN INSULIN 1ML 30GX5/16 SYRINGE, PISTON

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COVIDIEN MAGELLAN INSULIN 1ML 30GX5/16 SYRINGE, PISTON Back to Search Results
Model Number 8881893010
Device Problem Fail-Safe Problem (2936)
Patient Problem Needle Stick/Puncture (2462)
Event Date 03/03/2020
Event Type  Injury  
Manufacturer Narrative
A representative sample has been requested but to date has not been received for evaluation. If a 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
The customer reported that the nurse was administering sc insulin and after the procedure she went to use the safety catch and the needle punctured through the side of the safety catch resulting in a needle stick injury. The patient is (b)(6). The safety shield was activated by the nurse with her hands and it moved freely but the needle came out of the side. The customer is unsure if an audible click was heard after activating the shield. The nurse was given a (b)(6) booster and bloods for storage. Blood test were completed and all results were normal. The nurse will be given a (b)(6)booster as follow up medical intervention.
 
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Brand NameMAGELLAN INSULIN 1ML 30GX5/16
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 Key10423088
MDR Text Key203487577
Report Number1915484-2020-01182
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
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881893010
Device Catalogue Number8881893010
Device Lot Number12517X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/18/2020 Patient Sequence Number: 1
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