MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNIFINE PENTIPS 31G X 8MM; PEN NEEDLES

Model Number	AN 3530
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Distress (2329); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient has returned pentip that she used but has not yet returned the medical questionnaire with details.The patient admits reusing her pen needles 2-3 times per injection before changing pen needles.Used pentip hub (minus the needle) has been returned to our manufacturer for evaluation.
Event or Problem Description
Customer called in to let us know that she had given herself an injection and when she went to remove the needle from her skin, the needle remained in her skin.She went to the emergency room where they did a sonogram and located the needle, however, would not attempt to remove the needle.The er advised her to wait and see if it expelled itself because going to remove it surgically would cause more damage to her.The patient admitted to using her pen needles 2-3 times before changing the needle, in spite of instructions to use the needle only one time.She was instructed again to follow the instructions, to use the pen needles one time and discard in a sharps container.
Additional Manufacturer Narrative
Third party manufacturer investigated sample provided by patient under magnification.The device showed evidence of reuse, with folding of the glue and cannula, which indicated the needle broke due to misuse.Patient admitted reusing needle multiple times before the break.Reuse of a needle will cause it to break.Investigation reports attached.Attachment: [gbc-19-05894 - e53-4460.Pdf, sr_1_1405405338_om_update.Pdf].

• Brand Name: UNIFINE PENTIPS 31G X 8MM
• Common Device Name: PEN NEEDLES
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 9507180
• Report Number: 8021764-2019-00016
• Device Sequence Number: 1202825
• Product Code: FMI
• UDI-Device Identifier: 00384703530010
• UDI-Public: 00384703530010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020
• Report Date (Section F): 12/20/2019

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: Lay User/Patient
• Device Expiration Date: 03/01/2022
• Device Model Number: AN 3530
• Device Catalogue Number: AN3530
• Device Lot Number: 1703722.U038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/20/2019
• Device Age: 31 MO
• Event Location: Other
• Date Report to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 08/25/2020
• 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: 82 YR
• Patient Weight: 82
• Date Report Sent to FDA: 12/20/2019