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

Model Number	31G X 8MM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
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.
Event or Problem Description
User has had several pen needles that he says were defective.A few were bent and he still injected.Then he saved 3 that were defective and bent into a z.

• Brand Name: MEMBER'S MARK PEN NEEDLES
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 7776169
• Report Number: 9613304-2018-00007
• Device Sequence Number: 11374414
• Product Code: FMI
• UDI-Device Identifier: 10078742257751
• UDI-Public: (01)10078742257751(17)220901(10)X56Y4
• 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): 07/18/2018

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 8MM
• Device Catalogue Number: 8933
• Device Lot Number: X56Y4
• 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: 07/18/2018
• 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