MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 25X1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833510
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2021
Type of Reportable Event	Malfunction
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 a syringe detached from a needle while administering the vaccine.The vaccinator states that the needle was advanced into the patient's arm, injecting the vaccine, however, as she removed the needle the syringe detached from the needle causing the needle to remain in place and some of the vaccine to expel onto the patients arm and the vaccinator face.The customer believes that greater than 50% of the vaccine was received.Cdc guidelines were reviewed with the patient concerning this scenario.The patient was given the option to receive an additional dose in the opposite arm per the guidelines.The patient refused.Additional information provided on 27-apr-2021 stated that the patient was receiving the covid19 vaccine.The needle was removed manually by the vaccinator.There was no injury or harm to the vaccinator.There was no injury to the patient besides the needle remaining in the patient after the vaccinator tried to initially remove it from the patient.
Additional Manufacturer Narrative
On (b)(6) 2021 the customer confirmed the device was discarded and will not be returned for evaluation.Type of investigation: (b)(4).Device available for evaluation: updated from yes to no.

• Brand Name: MAGELLAN 3ML SFTY COMBO 25X1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11734900
• Report Number: 1017768-2021-00931
• Device Sequence Number: 4092204
• Product Code: FMI
• UDI-Device Identifier: 10884521005839
• UDI-Public: 10884521005839
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: Health Professional
• Device Model Number: 8881833510
• Device Catalogue Number: 8881833510
• Device Lot Number: 724912
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR