MAUDE Adverse Event Report: HTL-STREFA S.A. TEECHLITE; PEN NEED;E

Model Number	32G X 4MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint received on techlite pen needles lot z58f2.The customer is claiming that about 30 needles were bent or bending (in use on the patient side of the needle).There was no needle at all on one of the pen needles.

• Brand Name: TEECHLITE
• Common Device Name: PEN NEED;E
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• MDR Report Key: 9669783
• Report Number: 9613304-2020-00004
• Device Sequence Number: 19529000
• Product Code: FMI
• UDI-Device Identifier: 10015482234321
• UDI-Public: (01)10015482234321(17)20240501(10)Z58F2
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 01/30/2020

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: 05/01/2020
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8647
• Device Lot Number: Z58F2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1