MAUDE Adverse Event Report: COVIDIEN PREVENT NEEDLE ONLY 25 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	26559
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/05/2021
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 that when administrating a vaccine to a child, the needle came out of the safety part as she was pulling the needle out after administering the vaccine.It was about ¾ of the way out when the needle came off and she was easily able to pull the needle out.Additional information was received from the customer and stated that the vaccine was given to a (b)(6) year-old child.Per customer, the needle was detached and was still in child¿s leg.The customer was able to remove the detached needle with no injury.

• Brand Name: PREVENT NEEDLE ONLY 25 X 1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12350271
• Report Number: 1017768-2021-00973
• Device Sequence Number: 4181755
• Product Code: FMI
• UDI-Device Identifier: 10612479201382
• UDI-Public: 10612479201382
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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
• Device Model Number: 26559
• Device Catalogue Number: 26559
• Device Lot Number: 026519
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 YR
• Patient Sex: Unknown