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

Model Number	8881893010
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: MAGELLAN INSULIN 1ML 30GX5/16
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10423088
• Report Number: 1915484-2020-01182
• Device Sequence Number: 14151900
• Product Code: FMF
• UDI-Device Identifier: 10884521005952
• UDI-Public: 10884521005952
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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 Number: 8881893010
• Device Catalogue Number: 8881893010
• Device Lot Number: 12517X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other