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

Model Number	AH+2732-1M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient needed a chest tube placed in left chest.Provider was injecting local anesthetic and the needle broke off into the subcutaneous chest wall tissue.Unable to retrieve the needle.Patient then taken into the operating room.Additional information received 11/08/2022: patient was taken to the or (operating room) from the ed (emergency department).The needle had moved 3 to 4 inches from the original insertion site.Needle was obtained using imaging (2 plain).Patient was not harmed any further from this event.Patient ultimately had the needle removed and the chest tube placed while in the or where she was then transferred to a higher level of care.

• 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: 15872520
• Report Number: 1056186-2022-00018
• Device Sequence Number: 2468825
• Product Code: FMI
• UDI-Device Identifier: 00383790002134
• UDI-Public: 00383790002134
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2022
• Report Date (Section F): 11/28/2022

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: 09/30/2026
• Device Model Number: AH+2732-1M
• Device Catalogue Number: AH+2732-1M
• Device Lot Number: 21J10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/24/2022
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2022
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/28/2022