MAUDE Adverse Event Report: Cardinal Health, Inc. Monoject; Needle, Hypodermic, Single Lumen

Model Number	1188827112
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician inserted a 27g 1 1/2" monoject standard hypodermic needle to provide local anesthetic and when the needle was removed, there was no needle on the hub.Additional information received on 05 aug 2026 stated that that the needle was retained in the patient and based on follow up ct scan it was deemed unsafe to remove.On (b)(6) 2026 it was stated that the needle is in the patient's lung parenchyma.The patient has been discharged from the hospital.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: Monoject
• Common Device Name: Needle, Hypodermic, Single Lumen
• Manufacturer (Section D): Cardinal Health, Inc.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): Cardinal Health; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; +1(508)316-3640
• MDR Report Key: 50567869
• Report Number: 1423537-2026-00275
• Device Sequence Number: 18620356
• Product Code: FMI
• UDI-Device Identifier: 10884521007444
• UDI-Public: (01)10884521007444(10)25E301
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K854547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2026

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?: Yes
• Device Model Number: 1188827112
• Device Catalogue Number: 1188827112
• Device Lot Number: 25E301
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown