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

Model Number	32G X 6MM
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tests on archival sample were performed for compliance with the parameters established in product specifications.No defects or other nonconformities were found.The tests on customer sample were performed for compliance with the parameters established in product specifications.The defects under complaint were not confirmed in the sample from customer.
Event or Problem Description
User is not able to use or prime insulin pen needle.Probably needles were bent.
Additional Manufacturer Narrative
Method code changed.
Event or Problem Description
User is not able to use or prime insulin pen needle.Probably needles were bent.
Additional Manufacturer Narrative
The tests on customer sample were performed for compliance with the parameters established in product specifications.The defects under complaint were not confirmed in the sample from customer.The probable cause of such defect was non-axial twisting pen needle on pen injector.
Event or Problem Description
User is not able to use or prime insulin pen needle.Probably needles were bent.

• Brand Name: TECHLITE 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: 7804431
• Report Number: 9613304-2018-00011
• Device Sequence Number: 11085354
• Product Code: FMI
• UDI-Device Identifier: 00015482236328
• UDI-Public: (01)00015482236328(17)220601(10)X56P7
• 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,Followup
• Report Date (Section B): 08/08/2018

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: Other
• Device Expiration Date: 06/01/2022
• Device Model Number: 32G X 6MM
• Device Catalogue Number: 8648
• Device Lot Number: X56P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 08/13/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 10/23/2018; 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1