MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET; (01)15907996092694(17)240701(10)Z58M2

Model Number	32G X 4MM
Medical Device Problem Codes	Partial Blockage (1065); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Lw received 1 box of 32g x 4mm from humana with lot no.Z58m2.She injects lantus 4x per day with a lantus solostar pen.She states pn doesn't correspond with the pen.She said the needles do not go into her stomach.She stated that the insulin literally leaks out her skin.She used the product for a week and had an issue every single time so, she went to the pharmacy and bought the bd brand that she was used to getting and hasn't had an issue since.

• Brand Name: DROPLET
• Common Device Name: (01)15907996092694(17)240701(10)Z58M2
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• MDR Report Key: 9608122
• Report Number: 9613304-2020-00001
• Device Sequence Number: 18979084
• Product Code: FMI
• UDI-Device Identifier: 15907996092694
• UDI-Public: (01)15907996092694(17)240701
• 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: 01/07/2024
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8315
• Device Lot Number: Z58M2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1