MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET PEN NEEDLES 31G X 5MM

Model Number	31G X 5MM
Medical Device Problem Codes	Failure to Prime (1492); Infusion or Flow Problem (2964); No Flow (2991)
Health Effect - Clinical Codes	Hyperglycemia (1905); Discomfort (2330)
Type of Reportable Event	Malfunction
Event or Problem Description
"patient received 4 total boxes of droplet pen needles, 31g x 5mm with lot number: b56y7.Patient received 2 boxes initially, experienced problems, received an additional 2 boxes, and continued to experience problems.Patient is new to the droplet brand, and she has been using (other brand) needles for about 25 years.She has never experienced this problem before.Patient claims that many of the pen needles would not prime.She would attempt to prime the pen needles 3-5 times before the insulin pen forcefully ejected a larger amount of insulin than was last dialed: as though the pen was backed up and then shot out all the insulin that was backed-up at once.Patient would then change the pen needle and try a different one.Patient also reported that, after some of her injections, her blood sugar remained high.She claims that she would be "up all night" attempting to inject insulin to correct her sugar with no success.Patient eventually switched back to (other brand) needles and has not experienced any problems since.Patient did not seek out or receive medical attention as a result of her high blood sugar.She reports no other adverse health effects other than high blood sugar and feeling bad.Patient injects 16 units of insulin in the morning and 7 units of insulin at night using the lantus solostar pen.Patient also injects up to 3 units of insulin 6 times a day with the humalog jr.Kwikpen.Patient claims that the pharmacist at her kroger claims that other uses have had this issue before.Htl inc records only show one other complaint coming from kroger in indianapolis.We are not replacing the needles, but we are expecting samples.".

• Brand Name: DROPLET PEN NEEDLES 31G X 5MM
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer Contact: justyna zemigala ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035
• MDR Report Key: 16563406
• Report Number: 9613304-2023-00003
• Device Sequence Number: 20223993
• Product Code: FMI
• UDI-Device Identifier: 05907996093069
• UDI-Public: (01)05907996093069(17)260901(10)B56Y7
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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: 09/01/2026
• Device Model Number: 31G X 5MM
• Device Catalogue Number: 8310
• Device Lot Number: B56Y7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female