MAUDE Adverse Event Report: HTL-STREFA S.A. TECHLITE PEN NEEDLES

Model Number	32G X 8MM
Medical Device Problem Codes	Failure to Prime (1492); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the archival sample was conducted on (b)(6) 2017 for compliance with the parameters established in product specifications zn-2014/htl- 810.02 , rev.6.No deviations such as bent needles, non-axiality or others which could cause the defect under complaint were observed.No deviations were observed in the archival sample which could cause the defect under complaint - the product meets the requirements of product specifications.
Event or Problem Description
Caller said several pen needles have bent needles.When looking inside the needle, the bottom needle is bent, and unable to prime the needle.Lot number w46za9 - 32g - 5/16 of an inch.Blue stripe on package.
Event or Problem Description
Caller said several pen needles have bent needles.When looking inside the needle, the bottom needle is bent and unable to prime the needle.Lot number w46za9-32g-5/16 of an inch.Blue stripe on package.
Additional Manufacturer Narrative
Analysis of the archival sample was conducted on 2018-01-15 for compliance with the parameters established in product specifications zn-2014/htl- 810.02 , rev.6.No deviations such as bent needles, non-axiality or others which could cause the defect under complaint were observed.No deviations were observed in the archival sample which could cause the defect under complaint - the product meets the requirements of product specifications.On 2018-01-19 samples from the customer were obtained.No deviations were observed during the customer sample testing.Such bending of the device-side needle, which was complained, can be obtained by incorrect, non-axial screwing of the needle on the device.In the samples provided, no other defects in details or assembly defects that could give rise to the issue under complaint were found.
Additional Manufacturer Narrative
Analysis of the archival sample was conducted on 2018-01-15 for compliance with the parameters established in product specifications zn-2014/htl- 810.02 , rev.6.No deviations such as bent needles, non-axiality or others which could cause the defect under complaint were observed.No deviations were observed in the archival sample which could cause the defect under complaint - the product meets the requirements of product specifications.On 2018-01-19 samples from the customer were obtained.No deviations were observed during the customer sample testing.Such bending of the device-side needle, which was complained, can be obtained by incorrect, non-axial screwing of the needle on the device.In the samples provided, no other defects in details or assembly defects that could give rise to the issue under complaint were found.Corrected data: this outcome provided in the initial report do not relate to the malfunction which was reported.Reported product was not reprocessed or reused on a patient.
Event or Problem Description
Caller said several pen needles have bent needles.When looking inside the needle, the bottom needle is bent and unable to prime the needle.Lot number w46za9-32g-5/16 of an inch.Blue stripe on package.

• Brand Name: TECHLITE PEN NEEDLES
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 7205058
• Report Number: 9613304-2018-00001
• Device Sequence Number: 13677054
• Product Code: FMI
• UDI-Device Identifier: 00015482238322
• UDI-Public: (01)00015482238322(17)190630(10)W46ZA9
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2018

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: 06/30/2019
• Device Model Number: 32G X 8MM
• Device Catalogue Number: 8649
• Device Lot Number: W46ZA9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 01/10/2018; 01/10/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/15/2018; 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening