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

Model Number	31G X 5MM
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 31g x 5mm pm from humana with lot no.Z58p1.He injects 35 units of lantus 1x per day.He emailed stating that, "1 in 3 will not work.Nothing will come out of them.User claims that he is losing lantus solo start and needles too.User is injecting correctly and he does not reuse needles based on collected information from user.

• Brand Name: DROPLET
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow 95-03 5; PL 95-035
• MDR Report Key: 9797345
• Report Number: 9613304-2020-00005
• Device Sequence Number: 2890916
• Product Code: FMI
• UDI-Device Identifier: 05907996093069
• UDI-Public: (01)05907996093069(17)240801(10)Z58P1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171982
• 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): 02/11/2020

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: 08/01/2024
• Device Model Number: 31G X 5MM
• Device Catalogue Number: 8310
• Device Lot Number: Z58P1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1