MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO HYPODERMIC NEEDLES

Model Number	AH+3013-1M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was injecting the left side of the neck, during the epidermal inclusion cyst excision, using needle.When retracting, the syringe, the needle became detached from the needle hub and was no longer attached to cap.Instead it remained in injection site with no way of retrieving.Patient saw a plastic surgeon, who was unable to remove the needle.Patient is scheduled for a second visit with a plastic surgeon.No further information has been provided.
Event or Problem Description
Patient was injecting the left side of the neck, during the epidermal inclusion cyst excision, using needle.When retracting, the syringe, the needle became detached from the needle hub and was no longer attached to cap.Instead it remained in injection site with no way of retrieving.Patient saw a plastic surgeon, who was unable to remove the needle.Patient is scheduled for a second visit with a plastic surgeon.No further information has been provided.
Additional Manufacturer Narrative
The manufacturer invesvestigation report attached is on retained samples only.Customer did not return the sample(s) for investigation.

• Brand Name: NIPRO HYPODERMIC NEEDLES
• Common Device Name: HYPODERMIC NEEDLES
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• MDR Report Key: 9832557
• Report Number: 8041145-2020-00003
• Device Sequence Number: 14185352
• Product Code: FMI
• UDI-Device Identifier: 00383790002141
• UDI-Public: 00383790002141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: AH+3013-1M
• Device Catalogue Number: AH+3013-1M
• Device Lot Number: 18K08
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/13/2020
• 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; Required Intervention