MAUDE Adverse Event Report: OWEN MUMFORD LTD UNIFINE PENTIPS 31G X 6MM; PEN NEEDLE

Model Number	AN 3590
Medical Device Problem Codes	Off-Label Use (1494); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Anxiety (2328); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's mother called in on (b)(6) 2020 to report that the night before when she injected her son using om 31g 6mm lot 1909755, the pen needle broke off into the patient's leg.She reported they took him and the pen needle to the emergency room and that the hub was left at he emergency department.She reported that she has a zoom consult with a surgeon to determine if any other actions are necessary.Follow up with the patient's mother indicated the doctor said they would just have to wait for the needle to come out on its own.The patient's mother reported she was injecting a growth hormone, gentropin.The ifu for gentropin instructs the users to only use 29g, 30g or 31g pen needles manufactured by beckton dickson.Owen mumford has not tested gentropin with om pen needles and there is a compatibility chart included on the packaging with drugs and pens that om has tested and claims compatibility with.Gentropin is not listed here.

• Brand Name: UNIFINE PENTIPS 31G X 6MM
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): OWEN MUMFORD LTD; brook hill; woodstock, oxfordshire OX10 1TU; UK OX10 1TU
• MDR Report Key: 10448327
• Report Number: 8021764-2020-00005
• Device Sequence Number: 4043914
• Product Code: FMI
• UDI-Device Identifier: 00384703590014
• UDI-Public: 00384703590014
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 07/10/2020
• Report Date (Section F): 07/10/2020

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: Other
• Device Expiration Date: 09/01/2024
• Device Model Number: AN 3590
• Device Catalogue Number: AN3590
• Device Lot Number: 1909755
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Event Location: Home
• Date Report to Manufacturer: 06/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2020
• Initial 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: 5 YR
• Patient Weight: 15
• Date Report Sent to FDA: 07/10/2020