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

Model Number	32G X 4MM
Medical Device Problem Codes	Material Fragmentation (1261); Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Missing Value Reason (3192)
Type of Reportable Event	Malfunction
Event or Problem Description
The patient loss 18 units of insulin due to the pn breaking off into her belly.Patient said medical attn was not required because, she was able to remove it as a splinter.The pen needles are dull and painful causing bruising.The pen needles bend at the injection site, and the labels had fallen off several of the pns (3 thus far).She does not reuse pen needles and she injects straight in opposed to pinching up.

• 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: 10060280
• Report Number: 9613304-2020-00016
• Device Sequence Number: 3082831
• Product Code: FMI
• UDI-Device Identifier: 05907996092697
• UDI-Public: (01)05907996092697(17)240701(10)Z58M1
• Combination Product (Y/N): N
• 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): 04/15/2020

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: 07/01/2024
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8315
• Device Lot Number: Z58M1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1