MAUDE Adverse Event Report: HTL-STREFA S.A. MEMBER'S MARK PEN NEEDLES

Model Number	31G X 6MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tests on archival sample were performed for compliance with the parameters established in product specification.No nonconformities were found.The tests on customer sample were performed for compliance with the parameters established in product specification.The defect under complaint was not confirmed.The defect could be caused potentially by incorrect screwing pen needles on pen injector.
Event or Problem Description
User complaint that she injects herself twice daily, husband injects once daily.Every few pen needles, the insulin does not come out.She is priming the pen.

• Brand Name: MEMBER'S MARK 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: 7776066
• Report Number: 9613304-2018-00005
• Device Sequence Number: 19281147
• Product Code: FMI
• UDI-Device Identifier: 10078742257744
• UDI-Public: (01)10078742257744(17)221101(10)X46ZK3
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 07/17/2018

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: 11/01/2022
• Device Model Number: 31G X 6MM
• Device Catalogue Number: 8932
• Device Lot Number: X46ZK3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1