MAUDE Adverse Event Report: HTL - STREFA INC. NEEDLE

Lot Number Y56A5

Device Problems Insufficient Flow or Under Infusion (2182); Inaccurate Delivery (2339)

Patient Problem Underdose (2542)

Event Date 06/09/2018

Event Type  Injury  

Event Description

Per pharmacist's narrative, pt states that he is having issues with the use of smaller pen needles; per pact pharmacist assessment, pt having difficulty with smaller pen needle delivering the full dose and has to try several different injections before the full dose is given.Insulin injection technique has been evaluated and it was deemed that pt was appropriately administering insulin.Used pen needle as directed for insulin injection; 1 units - prn - sq: (b)(6) 2017 through (b)(6) 2018.

• Brand Name: NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): HTL - STREFA INC.
• MDR Report Key: 7780277
• MDR Text Key: 117144118
• Report Number: MW5079091
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 8489831510
• UDI-Public: 8489831510
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: Y56A5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Weight: 59