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

Model Number	31G X 8MM
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
Patient received 2 boxes of droplet 31g x 8mm from va with lot no.Y58s6.He injects 30 units of lantus once a day and 16-18 units of novolog once a day with the corresponding pens.He called in today because, he states that his insulin is not dispensing when he tries priming the needles.Somehow the needle is clogged.He has gone through several needles and this has happened multiple times.He states that he does reuse needles but, this happens on the 1st attempt to use.

• Brand Name: DROPLET
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• MDR Report Key: 9556509
• Report Number: 9613304-2019-00089
• Device Sequence Number: 16722951
• Product Code: FMI
• UDI-Device Identifier: 15907996093059
• UDI-Public: (01)15907996093059(17)230601(10)Y58S6
• 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): 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 06/01/2023
• Device Model Number: 31G X 8MM
• Device Catalogue Number: 8309
• Device Lot Number: Y58S6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1