MAUDE Adverse Event Report: OWEN MUMFORD LIMITED PENTIPS; PEN NEEDLES

Model Number	AN 3430
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Anxiety (2328); Needle Stick/Puncture (2462)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is for personal use only, not for clinical use.
Event or Problem Description
A health professional was giving a patient an insulin shot "with" their personal use pen needles was stuck while attempting to recap the needle to take off the insulin pen; the needle went through the cap and punctured his left thumb.
Additional Manufacturer Narrative
Personal use pen needles were used in a clinical setting and when removing the needle from the pen, did not line up straight and therefore the needle went through the container.The container is not designed to be puncture resistant and is manufactured with a material that is consistant with alternative primary containers that are currently available on the market.This device is not defective if used in accordance with ifu and the needle is placed into the primary hub in a straight trajectory.The actual needle that went through the primary container was returned, but a photograph was provided to the third party manufacuterer due to health and safety risk.The original complaint that came through listed two separate health professionals and therefore was split into two separate files for reporting (a & b).

• Brand Name: PENTIPS
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 8558081
• Report Number: 8021764-2019-00009
• Device Sequence Number: 2256824
• Product Code: FMI
• UDI-Device Identifier: 00384703430020
• UDI-Public: 00384703430020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019
• Report Date (Section F): 04/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: AN 3430
• Device Lot Number: 1708738.V367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/09/2019
• Device Age: 20 MO
• Event Location: Other
• Date Report to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Weight: 59
• Date Report Sent to FDA: 04/26/2019