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	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was not returned for evaluation.Dhrs were reviewed and no records confirming the defect were observed.10 random pen needles from archival sample were selected for testing.All pen needles were tested by triple puncture into a silicone cube with a hardness of 55 shore imitating human tissue.No defects observed.If complaint 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 sent email saying needles were bent.Called customer to gather more information.Part 236132.When she takes the first cover off and when she removes the needle cover, the needle is bent along with the needle cover sleeve.Replaced product and sent rl.(b)(4).
Additional Manufacturer Narrative
Dhrs were reviewed.No records confirming the defect were observed.10 pen needles from archival sample were tested with triple puncture into a silicone cube with a hardness of 55 shore (imitating the hardness of human tissue).No defects were observed during test.Additionally, 10 pen needles from returned sample were tested with triple puncture into a silicone cube with a hardness of 55 shore (imitating the hardness of human tissue).No defects were observed during test.Defect was not confirmed.Based on the description, the bending on the user-end was created during the removing of the inner protective cap.When the inner protective cap si removed non-axially from the pen needle the patient may damage needle and bend it.This is clearly outlined in step 3 of the ifu.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: 8889381
• Report Number: 1832816-2019-00014
• Device Sequence Number: 311726
• Product Code: FMI
• UDI-Device Identifier: 00015482236328
• UDI-Public: (01)00015482236328
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: 10/01/2023
• Device Model Number: 236132
• Device Catalogue Number: 236132
• Device Lot Number: Y56ZC8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1