MAUDE Adverse Event Report: HTL-STREFA S.A. DROPSAFE; PEN NEEDLE

Model Number	31G X 6MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lack of samples from customer level.
Event or Problem Description
'i was just made aware of a needle stick that occurred in our (b)(6) facility using one of the drop safe pen needles that came out of the side of the device.Additional details - here is the info regarding the needle stick:.The nurse - she was attempting to remove the used needle at the end of the insulin pen, the needle was bent through one of the opening on the drop safe pen needles and it came out of the side of the device.She quickly reported and showed the supervisor what had happened.We sent her to (b)(6) lab for blood draw and the first round of results were negative.She will follow the serial lab testing protocol until completed'.

• Brand Name: DROPSAFE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow 95-03 5; PL 95-035
• MDR Report Key: 9271437
• Report Number: 9613304-2019-00077
• Device Sequence Number: 16171619
• Product Code: FMI
• UDI-Device Identifier: 05907996091584
• UDI-Public: (01)05907996091584(17)220601(10)Z55M8
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 06/01/2022
• Device Model Number: 31G X 6MM
• Device Catalogue Number: 8162
• Device Lot Number: Z55M8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 11/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention