MAUDE Adverse Event Report: HTL-STREFA S.A. TECHLITE PEN NEEDLES; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	236132
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was not returned for evaluation.Manufacturer tested retention samples of the same lot of pen needles involved in the incident and performed to specification.No failure detected.If product is returned, arkray will send to manufacturer for testing and file a follow-up report when evaluation is complete.
Event or Problem Description
Caller states that sometimes she is not able to use or prime insulin pen needle.She is a diabetic educator and states that she knows what she is doing.She doesn't like the product and will not recommend to her patients.I had her check two of them that wouldn't work yesterday, and the needle was bent.She has been using these pen needles for about two months and this has been an ongoing issue.I did mention to try to make sure that the cap is put on directly and make sure not accidentally bending the needle when putting cap on pen.Part 236132.Replaced product and sent rl.Possible malfunction that may cause improper dose or delay in treatment.
Additional Manufacturer Narrative
Dhrs were reviewed.No records confirming the defect were observed.10 pen needles from archival sample were tested by puncturing into the silicone cube with the hardness of 55 shore (imitating the hardness of human tissue.No hooks occured.No bending of the needle occured.Complaint sample consisted of 8 pen needles without the seals from which 3 pen needles were without the outer protective cap.In 4 pen needles the bent defect was observed on the non-user end.The other 4 needles were bent on patient end.Further investigation through microscope showed needles were damaged during incorrect assembly by the user.Dull and bent needles are generally connected with user error when the protective cap is removed incorrectly.Improper use.No corrective action.Complaint closed.

• Brand Name: TECHLITE PEN NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-035 ozorkow; PL
• MDR Report Key: 7842258
• Report Number: 1832816-2018-00018
• Device Sequence Number: 16639538
• Product Code: FMI
• UDI-Device Identifier: 00015482236328
• UDI-Public: (01)00015482236328
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: 06/01/2022
• Device Model Number: 236132
• Device Catalogue Number: 236132
• Device Lot Number: X56P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1