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

Model Number AN 3530

Device Problem Material Separation (1562)

Patient Problems Distress (2329); Discomfort (2330)

Event Type  Injury  

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 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.

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
• Type of Device: PEN NEEDLES
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 9507180
• MDR Text Key: 178314957
• Report Number: 8021764-2019-00016
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00384703530010
• UDI-Public: 00384703530010
• Combination Product (y/n): N
• PMA/PMN Number: K152339
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/20/2019,08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 12/20/2019
• Distributor Facility Aware Date: 11/20/2019
• Device Age: 31 MO
• Event Location: Other
• Date Report to Manufacturer: 11/20/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 82