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

Model Number	234132
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was returned for evaluation and forwarded to the manufacturer for further evaluation.Evaluation results are pending.Arkray will file a follow-up report when evaluation is complete.
Event or Problem Description
Caller said these were 32g x 4mm needles in a 100ct box that was white in color.Caller was unable to find lot or batch number but found product number of 234132.Caller says the needles they use bend after being inserted in their skin.Caller also says they do not get the full amount of insulin and need to use a second needle.I made sure caller applied cap correctly by placing straight on.Caller injects at 90-degree angle.Caller said they did not inject into scar tissue.I told caller we can replace the needles and explained the return process as we would like it back for some testing.Replaced devices and sent rl.Contacted customer after initial call and was able to gather the lot number.
Additional Manufacturer Narrative
Manufacturer's investigation completed.Dhr's were reviewed and no records confirming the defect were observed.10 pen needles from archival sample and all returned samples were assembled onto pen injector and were triple punctured with proper technique into silicone cube with a hardness imitating human skin.No defects were observed during testing.10 pen needles from archival sample and all returned samples were assembled onto pen injector and tested for fluid flow.Droplets on the cannula were observed and injection of the applied dose could be observed.No defects observed during testing.

• 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: 11790231
• Report Number: 1832816-2021-00011
• Device Sequence Number: 3972931
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 05/24/2021

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: 09/01/2021
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: A58T8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1