MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 23X1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833310
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional 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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that they had an employee exposure with a needle stick.The nurse was giving an agitated patient an im injection.When she went to engage the safety lock on the syringe, the needle flew off the syringe and into the bed.The nursing assistant tried to reposition the patient so he wouldn¿t get stuck with the needle and ended up getting stuck herself.They are not sure if there is an issue with the lot or anything related to the product itself.It is possible that the nurse used a red blunt tip to draw up the medication and then screwed the 23g needle back on for injection.If so, the needle may not have been screwed on tight enough, which might be the reason it came off of the syringe.Additional information provided by the customer on june 09, 2021 stated that the entire needle luer hub assembly detached from the syringe barrel.The nurse had used her thumb to activate the safety shield.She did not use a red blunt tip, she drew up the medication with the 23g needle itself.The customer further stated that they cannot share any information regarding any medical intervention, testing, or the current status of the nursing assistant without the consent of the involved parties.
Additional Manufacturer Narrative
A device history record (dhr) for the reported lot did not indicate any exception that could lead to the reported incident.A product analysis was unable to be completed as to date no samples have been provided.A photograph was submitted with this complaint however the reported condition could not be confirmed solely on the photograph as the product could not be identified in the photo.Precluding any further information or evidence there is not enough information at this time to determine with any confidence what likely caused the reported issue; therefore, the root cause is undetermined.If additional information or evidence becomes available, the complaint will be reopened and the root cause reassessed.Based on the information available and the investigation findings, a formal investigation is not deemed necessary at this time.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: MAGELLAN 3ML SFTY COMBO 23X1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11982163
• Report Number: 1017768-2021-00950
• Device Sequence Number: 3425815
• Product Code: FMI
• UDI-Device Identifier: 10884521005815
• UDI-Public: 10884521005815
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 8881833310
• Device Catalogue Number: 8881833310
• Device Lot Number: 108843
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 09/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other