MAUDE Adverse Event Report: EXELINT INTERNATIONAL EXEL HYPO NDL 27GX1-1/2"; HYPODERMIC NEEDLE

Model Number	26426
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per clinic manager: "on (b)(6) 2024 one of our provider's reported the needle cleanly detached itself from the hub during the procedure.There was no evidence of needle breakage or fracture from the hub.The needles were purchased from mckesson." the following information was provided via telephone conversation between exel qa specialist and the clinic manager: patient was at the pain management center of the hospital for trigger point therapy to inject lidocaine to the superior aspect of lumbar midline.It was reported that exel hypo ndl 27gx1-1/2" p/n: 26426, lot #230602 needle broke from the siring hub and lodged in the patient.The procedure was completed using another needle from the same lot.The patient was sent to urgent care where the physician performed a superficial incision and was able to successfully removed the needle.The incision was sutured and the patient is stated to be well.The clinic manager reported that this is the first incident with a broken needle and that its not happened before with the same or other brands.No images of the damaged needle were taken and neither the needle nor syringe were retained.It was stated that the pt did not have any other issues or disease to report.
Additional Manufacturer Narrative
On 2/7/24 the clinic manager stated: per physician at the time of the event from what could be seen, was that the needle seemed to have a clean detachment from the hub when withdrawing the needle.Did not appear to have a break.Lidocaine was injected to the right paraspinal lumbar muscles, around the upper lumbar levels and not directly midline.
Additional Manufacturer Narrative
Per investigation report sent by oem on 28-feb-2024 and 01-mar-2024: retention samples were tested and production process records were reviewed.No issues were noted.There are no other similar complaints from this lot.Based on the available complaint information (no returned product or complaint images), a potential root cause is no adhesive or insufficient adhesive between the needle tube and the needle hub.The manufacturing machine can detect missing adhesive in real time.Additionally, samples are tested for adhesive strength during manufacturing, and a firmness test is conducted for each lot.There is a low probability that there is no adhesive or insufficient adhesive that would cause the needle tube to separate from the needle hub.Due to a clean detachment from the hub when withdrawing the needle, this incident is not related to the needle breaking.

• Brand Name: EXEL HYPO NDL 27GX1-1/2"
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): EXELINT INTERNATIONAL; 2500 santa fe avenue; redondo beach CA 90278
• Manufacturer Contact: vu doan ; 2500 santa fe avenue; redondo beach, CA 90278
• MDR Report Key: 18664758
• Report Number: 1035907-2024-00001
• Device Sequence Number: 12851471
• Product Code: FMI
• UDI-Device Identifier: 00020221264265
• UDI-Public: (01)00020221264265
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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?: No
• Device Model Number: 26426
• Device Lot Number: 230602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown