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.
Additional Manufacturer Narrative
Initial investigation report attached is on retained samples by the manufacturer.Awaiting unused samples to be returned by the end user to perform final investigation.
Additional Manufacturer Narrative
Initial investigation report attached is on retained samples by the manufacturer.Awaiting unused samples to be returned by the end user to perform final investigation.On 02/09/2023: final investigation report attached is on returned unused samples from the customer.Actual used sample was discarded.
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 on 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,
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 15872295
• Report Number: 8041145-2022-00013
• Device Sequence Number: 19446499
• Product Code: FMI
• UDI-Device Identifier: 00383790002134
• UDI-Public: 00383790002134
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown