MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; NEEDLE,HYPODERM,SAFETY, 25GX1

Catalog Number SSN100255

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/29/2023

Event Type  Injury  

Event Description

According to the facility on (b)(6) 2023 "the medical assistant inserted the syringe into the arm, administered the vaccine and when pulling the needle out of the deltoid of patients arm, the needle came disconnected from the plastic safety cap".

Manufacturer Narrative

According to the facility on (b)(6) 2023 "the medical assistant inserted the syringe into the arm, administered the vaccine and when pulling the needle out of the deltoid of patients arm, the needle came disconnected from the plastic safety cap".Per the facility "the medical assistant grabbed the needle and removed it from the patient's arm".Per the facility there was no injury or medical intervention that was reported related to the reported incident.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: NEEDLE,HYPODERM,SAFETY, 25GX1
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17806801
• MDR Text Key: 324117229
• Report Number: 1417592-2023-00384
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SSN100255
• Device Lot Number: 89721090001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other