MAUDE Adverse Event Report: ULTI MED, INC. ULTICARE SHORT PEN 31G X 8 MM; NEEDLE, HYPODERMIC, SINGLE LUMEN

Lot Number	7210106
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Using ulticare short pen 31g x 8 mm.Needle is very flexible and have several issues with it including the needle bending and penetrating the safety cap when bring recapped.Also have one instance where the needle was apparently bend before being capped resulting in the needle being collapsed into a spaghetti bowl.Fda safety report id # (b)(4).

• Brand Name: ULTICARE SHORT PEN 31G X 8 MM
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ULTI MED, INC.; excelsior MN 553
• MDR Report Key: 13026099
• Report Number: MW5106140
• Device Sequence Number: 5433173
• Product Code: FMI
• UDI-Device Identifier: 20357515095859
• UDI-Public: (01)20357515095859
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/15/2021
• 2 Devices were Involved in the Event: 1 2

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 Lot Number: 7210106
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2021
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White