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

Model Number	AH+2538-1M
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During a hormone pelleting procedure, needle broke off into the tissue of the right buttock.The needle broke off at the base near the plastic tip.Clinic is concerned the needle was defective as routine surgical procedure was followed and the protocol was followed with an experienced provider.The needle is still in the tissue and the clinic is attempting to get an interventional radiologist to assist at the removal, as general surgery was unsuccessful.08/05/2020: the patient eventually was able to get the needle removed.

• Brand Name: NIPRO HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• MDR Report Key: 10446253
• Report Number: 1056186-2020-00008
• Device Sequence Number: 4283399
• Product Code: FMI
• UDI-Device Identifier: 00383790002080
• UDI-Public: 00383790002080
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2020
• Report Date (Section F): 08/24/2020

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: 10/31/2021
• Device Model Number: AH+2538-1M
• Device Catalogue Number: AH+2538-1M
• Device Lot Number: 16K10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/29/2020
• Device Age: 45 MO
• Event Location: Other
• Date Report to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2020
• 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: Required Intervention
• Date Report Sent to FDA: 08/24/2020