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

Model Number	236132
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in the incident was returned to arkray usa and forwarded to the manufacturer for evaluation.We have not yet received evaluation results.Arkray will file a follow-up report when device evaluation is complete.
Event or Problem Description
Caller used to use bd pen needles.He was switched to the techlite pen needle, part 236132.Lot y46zp5 - 2023-12-01.Caller sets at two units to release the air then dial up to the dosage to the insulin amount that he's supposed to take.He stated that he's not able to press the plunger down, it was locked solid.He would remove the pen needle then screw it on then the insulin would release.He figured it couldn't be the dial up insulin pen because it happened on both dial up insulin pens.He thinks the issue is the pen needles.He received the pen needles about two months ago.I verified that he does removes the cover on the needle first then twists it on the insulin pen.Then he would remove the cover to reveal the top needle.He would adjust the dial to two units to release the air bubble, but it would jam.He was not able to release the air bubble or insulin.I walked him through the steps to unscrew a pen needle to twist on to the insulin pen then removed the cap.He adjusted the dial to two units and the released insulin.He also mentioned at time, he's revealed a needle and there was one bent.I explained that we will send the product through testing and will send a replacement along with a pre-paid return label.
Additional Manufacturer Narrative
Dhrs were reviewed.No records confirming the defect were observed.10 pen needles from archival and returned samples 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.10 pen needles from archival and returned samples were assembled on the pen injector.With every assembly attempt, droplets on the cannula were observed and injection of the applied dose can be seen, which is visible on the paper and confirms the correctness of the pen needle assembly on the pen and the patency of the needles.Fluid flow was obtained in all tested pen needles.No defects were observed during testing.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: 9249993
• Report Number: 1832816-2019-00027
• Device Sequence Number: 2030422
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: 12/01/2023
• Device Model Number: 236132
• Device Catalogue Number: 236132
• Device Lot Number: Y46ZP5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1