MAUDE Adverse Event Report: MEDSAFETY SOLUTIONS TWOFER HUBER TIPPED NEEDLE; TRANSFER NEEDLE

Model Number	16004
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Request has been made for additional details regarding the incident and to provide samples from the associated lot for evaluation.
Event or Problem Description
Received communication from product distributer located in finland that a customer reported "particles" observed in several batches of compounded solutions.The twofer needle was utilized in the compounding process.The 'incident date' was not reported.The reported incident had no patient involvement; it did not result or contribute to a death or serious injury.The incident is currently under investigation.

• Brand Name: TWOFER HUBER TIPPED NEEDLE
• Common Device Name: TRANSFER NEEDLE
• Manufacturer (Section D): MEDSAFETY SOLUTIONS; 11233 e. caley avenue; suite 300; centennial CO 80111
• Manufacturer Contact: rich weiskopf ; 11233 e. caley avenue; suite 300; centennial, CO 80111 ; 7205002500
• MDR Report Key: 20828087
• Report Number: 3013445787-2024-00001
• Device Sequence Number: 4058623
• Product Code: LHI
• UDI-Device Identifier: 00853832007071
• UDI-Public: (01)00853832007071(11)230101(17)260101(10)14334
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K832347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2026
• Device Model Number: 16004
• Device Catalogue Number: 16004
• Device Lot Number: 14334
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown