MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET; PEN NEEDLE

Model Number	31GX 8MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report connected with mdr 9613304-2019-00080.Customer sent back mix of 2 lot number.For one lot mfg submitted follow up report for second decided to submit separated initial mdr ( lot z58z5).
Event or Problem Description
Patient received 4 boxes of 31g x 8mm pen needles with lot no.S285a from the va.He is using a droplicon pen to insert 28 units of lantus once per day.He stated that he's had 2 pen needles break within the last week as he's trying to insert the needle into his abdomen.One he was able to pull out and the other is lost.He went to the er for an x-ray; however, nothing showed up so he doesn't know where it is.Patient stated he does not pinch up as he's injecting.I advised that with the 8mm pen, he should pinch up.I suggested a smaller needle if he is more comfortable with not pinching up and he was open.The lot number is not correct.Several attempts were made on the 18th to contact the patient to get the correct lot, but the patient did not answer nor have they called us back.The user's samples were send month ago and the lot number could be defined-y58z5.

• Brand Name: DROPLET
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• MDR Report Key: 9502799
• Report Number: 9613304-2019-00083
• Device Sequence Number: 13922839
• Product Code: FMI
• UDI-Device Identifier: 15907996093059
• UDI-Public: (01)15907996093059(17)230801(10)Y58Z5
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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: No Information
• Device Expiration Date: 08/01/2023
• Device Model Number: 31GX 8MM
• Device Catalogue Number: 8309
• Device Lot Number: Y58Z5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 12/20/2019
• Patient Sequence Number: 1