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

Model Number	32G X 4MM
Medical Device Problem Codes	Infusion or Flow Problem (2964); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Needle on pen needle cap bends and does not deliver insulin.Our pharmacy just changed manufacturers and have received two separate complaints.The problem product is: droplet pen needles, 100 in a box,.23mm x 4mm 32gauge x 5/32in.Lot#z58k5."exp date: 20240601".

• Brand Name: DROPLET
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 10470145
• Report Number: 9613304-2020-00025
• Device Sequence Number: 19604384
• Product Code: FMI
• UDI-Device Identifier: 05907996092697
• UDI-Public: (01)05907996092697(17)240601(10)Z58K5
• 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): 07/31/2020

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: Lay User/Patient
• Device Expiration Date: 06/01/2024
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8315
• Device Lot Number: Z58K5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1