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

Model Number	31G X 5MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Mr.(b)(6) called to advise that the needles are bending.He says the bend is where the needle meets the plastic at the top of the pen needle.Also, he hears a popping when they pierce the skin.They aren't painful, but do make noise.He is concerned that with the bend in the needle he isn't getting his full dose of insulin.He doses 4x's a day and uses novolog and lantus.He has noticed that the needle bends with both of this pens.He will retain any that bend moving forward until his replacement product arrives.However, he has disposed of the needles already that had previously bent.

• 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: 8615073
• Report Number: 9613304-2019-00059
• Device Sequence Number: 11500191
• Product Code: FMI
• UDI-Device Identifier: 05907996093069
• UDI-Public: (01)05907996093069(17)230401(10)Y56K3
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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: 04/01/2023
• Device Model Number: 31G X 5MM
• Device Catalogue Number: 8310
• Device Lot Number: Y56K3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1