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

Model Number	238131
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer states that she has been a paramedic for 30 years and she states she had an a1c of between 5-6 while using the comfort ez pen needles up until she began using the techlite pen needles on (b)(6) 2022.Since then, her a1c has increased to 7.1 per her physician and she feels that this is due to not being able to properly dose insulin due to the needles bending and not knowing how much insulin was being absorbed.She states that about 3-4 days after starting the techlite, one of the needles broke off and stayed in her stomach, but that she was able to remove it without medical intervention.She has not started any new medications or had any changes in doses.She is type 2 diabetic.She can see the bubble when she is priming, and she holds the needle in place to the count of 7 or 8.When pulling the needle, she finds that it is bent at 90° and/or realizes that there is insulin is on her clothes.She feels like end of needle is dull and she will not be using them anymore.Lot: b46zp1 - 2026-01-12.Part 238131.Caller started using them (b)(6) 2022 and purchased them at cvs pharmacy.She gives injections into her stomach at 90° and her blood glucose continues to rise and then she finds that the insulin has not gone into her and that the needle had bent, or she finds that it has leaked out and not been absorbed and she cannot give more insulin because she does not know how much of the insulin actually went into her body so she has to wait and see what it does.She also called the cvs pharmacy and advised them at the situation.Customer is willing to try the 4mm x 32g (part 234132) and return this box replacing with rl.
Additional Manufacturer Narrative
Complaint devices were returned on 8/2/2022 and forwarded to the manufacturer for further investigation.Returned complaint device investigation results are pending.On 7/21/2022, device history records were reviewed and no records confirming defects were observed.Archival samples were evaluated by verifying patency of cannula, assembling pen needles on pen injector, and verifying fluid flow, visually assessing needles for sharpness and length, conducting drag force and penetration tests, and conducting puncture tests.The defects under complaint were not confirmed in the archival samples and samples meet requirements of specification.Root cause analysis was not conducted as archival sample evaluation did not reveal any non-conformities.No capa initiated.A follow-up mdr will be filed with actual complaint device investigation results.
Additional Manufacturer Narrative
Returned samples were evaluated by verifying patency of cannula, assembling pen needles on pen injector, and verifying fluid flow, visually assessing needles for sharpness and length, conducting drag force and penetration tests, and conducting puncture tests.The defects under complaint were not confirmed in the returned samples and samples meet requirements of specification.Root cause analysis was not conducted as returned sample evaluation did not reveal any non-conformities.

• 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
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; 95-035 ozorkow; PL
• Manufacturer Contact: tom speikers ; 5182 w 76th street; minneapolis, MN 55439 ; 9526463168
• MDR Report Key: 15191073
• Report Number: 1832816-2022-00016
• Device Sequence Number: 12225172
• Product Code: FMI
• UDI-Device Identifier: 00015482238315
• UDI-Public: (01)00015482238315
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/12/2026
• Device Model Number: 238131
• Device Catalogue Number: 238131
• Device Lot Number: B46ZP1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female