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

Model Number	32G X 4MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
User received 1 box of droplet 32g x 4mm pns with lot no.Z58m5 from humana.She is injecting levimere 9 units 1x per day with the corresponding pen.She called in stating the insulin is getting stuck in the pn.She has to change out the pn multiple times in order to get the insulin to dispense.She does prime the pn and even in doing so, sometimes nothing comes out.

• Brand Name: DROPLET
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• MDR Report Key: 9669699
• Report Number: 9613304-2020-00003
• Device Sequence Number: 14180073
• Product Code: FMI
• UDI-Device Identifier: 15907996092694
• UDI-Public: (01)15907996092694(17)20240801(10)Z58M5
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 01/30/2020

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: 08/01/2024
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8315
• Device Lot Number: Z58M5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1