MAUDE Adverse Event Report: HTL STREFA S.A. MEMBERS MARK PEN NEEDLE

Model Number	31G X 6MM
Medical Device Problem Codes	Failure to Deliver (2338); No Flow (2991)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the archival sample was conducted on 2017-12-05 for compliance with the parameters established in product specifications zn-2014/htl- 810.02, rev.13.During testing, particular attention was paid to needle position on the non-patient end.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
(b)(6) called (b)(6) 2017 at approx.3:20pm and left a voicemail.(b)(6) had recently converted from easy touch to the members mark pen needles.(b)(6) explained that she was inserting the droplet pen needles into her humalog kwikpen, following the instructions provided with the product.However, somehow the interior needle that goes into the insulin vial was somehow becoming bent and not delivering her insulin.She reported that she had that experience with 4 pen needles.
Additional Manufacturer Narrative
Analysis of the archival sample was conducted on 2017-12-05 for compliance with the parameters established in product specifications zn-2014/htl- 810.02, rev.13.During testing, particular attention was paid to needle position on the non-patient end.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.Analysis of the archival sample was conducted on 2017-12-05 for compliance with the parameters established in product specifications zn-2014/htl- 810.02, rev.13.During testing, particular attention was paid to needle position on the non-patient end.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.Additionally 8 used pen needles were returned, including two pen needles with needles bent on the non-patient end.6 pen needles were tested with regard to screwing and unscrewing the pen needles on/off pen injector devices.Three designs of pen injector devices were used: - pre-filled pen injectors with insulin - lantus solostar, sanofi, - pen injectors with dedicated cartridges - novopen echo, novonordisk - pen injectors with typical, replaceable cartridges - tactipen, sanofi.Each test was successfully completed.A drop of fluid was observed at the end of the needle which confirms correct assembly of the needle on the pen injector and patency of the needle.Disassembly and verification of needles on the non-patient end also did not confirm the defect under complaint.The most likely cause of the defect under complaint is incorrect use during attachment (screwing) of the pen needle on the pen injector device.
Event or Problem Description
(b)(6) called (b)(6) 2017 at approx.3:20pm and left a voicemail.(b)(6) had recently converted from easy touch to the members mark pen needles.(b)(6) explained that she was inserting the droplet pen needles into her humalog kwikpen, following the instructions provided with the product.However, somehow the interior needle that goes into the insulin vial was somehow becoming bent and not delivering her insulin.She reported that she had that experience with 4 pen needles.

• Brand Name: MEMBERS MARK PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 7111809
• Report Number: 9613304-2017-00003
• Device Sequence Number: 1895698
• Product Code: FMI
• UDI-Device Identifier: 10078742257744
• UDI-Public: (01)10078742257744(17)220901(10)X56X9
• 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
• Report Date (Section B): 01/19/2018

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: 09/01/2022
• Device Model Number: 31G X 6MM
• Device Catalogue Number: 8932
• Device Lot Number: X56X9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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