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

Model Number	31G X 8MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer found 12 pen needles that were bent at a 90 degree angle after removing the safety cap.The needles weren't used, they were brand new.He disposed of the faulty needles.User also noticed that the blue safety cap wasn't there to cover the needle and stated the clear cap was the only cover on the pen needles.

• Brand Name: TECHLITE
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 9848575
• Report Number: 9613304-2020-00007
• Device Sequence Number: 13644549
• Product Code: FMI
• UDI-Device Identifier: 00015482238315
• UDI-Public: (01)00015482238315(17)241001(10)Z56W2
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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: No Information
• Device Expiration Date: 10/01/2024
• Device Model Number: 31G X 8MM
• Device Catalogue Number: 8646
• Device Lot Number: Z56W2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1