MAUDE Adverse Event Report: HTL STREFA S A DROPSAFE; 25G DROPSAFE SAFETY NEEDLE

Model Number	25G
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported an issue with the strefa product supplied in the kit, indicating that the safety doesn't always latch right away.Customer stated that it takes more pressure to get the safety to engage.The customer provided manufacturer product # 6059 and lot # sn25250018 as additional product identification information.
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that can contain the device from the manufacturer identified.The item ref # and lot # reported and identified in section d have been confirmed as having been used in the assembly of convenience kits supplied by mckesson medical-surgical, inc.We have notified (b)(6) for awareness.

• Brand Name: DROPSAFE
• Common Device Name: 25G DROPSAFE SAFETY NEEDLE
• Manufacturer (Section D): HTL STREFA S A; adamówek 7; ozorków, 95-03 5; PL 95-035
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland drive; richmond VA 23233
• Manufacturer Contact: jo ann silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 15781069
• Report Number: 3017368639-2022-00031
• Device Sequence Number: 11930866
• Product Code: FMI
• UDI-Device Identifier: 85907996099319
• UDI-Public: 85907996099319
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: 04/12/2026
• Device Model Number: 25G
• Device Catalogue Number: 6059
• Device Lot Number: SN25250018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown