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

Model Number	31G X 5MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Event or Problem Description
The pen needles are not going in smoothly and are very painful.The pen needles pressing into skin without puncturing, requiring force to puncture.Once injection is given, and needle is removed, patient complains of blood.
Event or Problem Description
The pen needles are not going in smoothly and are very painful.The pen needles pressing into skin without puncturing, requiring force to puncture.Once injection is given, and needle is removed, patient complains of blood.

• Brand Name: DROPLET PEN NEEDLES
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 8083682
• Report Number: 9613304-2018-00080
• Device Sequence Number: 1732487
• Product Code: FMI
• UDI-Device Identifier: 05907996093069
• UDI-Public: (01)05907996093069(17)230401(10)Y56H5
• 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,Followup
• Report Date (Section B): 11/06/2018

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: Y56H5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1