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

Model Number	32G X 4MM
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Bw received 2 boxes of 32g x 4mm from the va with lot no.Z58k6.He injects 18 units of lantus 1x per day with lantus solostar pen.He states that the pen needle doesn't allow a full injection.Ie: he injects 18 units and the injection stops at 5 and he has to switch needles in order to receive the rest of the injection.He stated this happens 1 out of every 5 pn's and sometimes, the pn just doesn't work at all.Mr.Wenzel does not prime his pns all the time but, has been lately.He does not reuse pns.

• Brand Name: DROPLET
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• MDR Report Key: 9608123
• Report Number: 9613304-2020-00002
• Device Sequence Number: 2677928
• Product Code: FMI
• UDI-Device Identifier: 15907996092694
• UDI-Public: (01)15907996092694(17)240601(10)Z58K6
• Combination Product (Y/N): N
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2020

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: No Information
• Device Expiration Date: 06/01/2024
• Device Model Number: 32G X 4MM
• Device Lot Number: Z58K6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1