MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNIFINE PENTIP; PEN NEEDLE

Model Number	AN 3550KRO
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer states that needle broke off in the side of her abdomen on (b)(6).She states she did her injection and when she pulled the needle out of her skin there was no needle on the hub.Customer did save the hub.Customer went to the doctor and then was sent to the er to get an x-ray.She stated that they didn't see the needle, but that it could be in her skin and just not visible given the small size of the needle and that the injection was near her pelvis and the bone would show up as the same color as the needle.Customer states that she is marking a circle around where the injection was given to watch for any type of swelling and infection, but it seems fine for now.She is going back to the doctor in march and it will be checked again to make sure everything is ok.Customer just wanted to let us know what happened in case anyone else had this issue and requests a new box of a different lot number because she is worried something may be wrong with the lot number she has.
Event or Problem Description
Customer states that needle broke off in the side of her abdomen on february 14th.She states she did her injection and when she pulled the needle out of her skin there was no needle on the hub.Customer did save the hub.Customer went to the doctor and then was sent to the er to get an x-ray.She stated that they didn't see the needle, but that it could be in her skin and just not visible given the small size of the needle and that the injection was near her pelvis and the bone would show up as the same color as the needle.Customer states that she is marking a circle around where the injection was given to watch for any type of swelling and infection, but it seems fine for now.She is going back to the doctor in march and it will be checked again to make sure everything is ok.Customer just wanted to let us know what happened in case anyone else had this issue and requests a new box of a different lot number because she is worried something may be wrong with the lot number she has.

• Brand Name: UNIFINE PENTIP
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU,; UK OX20 1TU,
• Manufacturer (Section G): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire, OX20 1TU; UK OX20 1TU
• Manufacturer Contact: jeanetta mckinley ; 1755 west oak common court; marietta, GA 30062 ; 7709772226
• MDR Report Key: 21633124
• Report Number: 8021764-2025-00003
• Device Sequence Number: 18024331
• Product Code: FMI
• UDI-Device Identifier: 00041260007224
• UDI-Public: 00041260007224
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K152339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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?: No
• Device Model Number: AN 3550KRO
• Device Lot Number: 23E7003, 24K7001
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2023
• 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): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 81 KG