MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL 1/2ML INS SYR 28GX1/2"; INSULIN SYRINGE

Catalog Number	26024
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
"one of the syringes had a bent needle and she was unable to use it".It was observed after removal of the cap.There are no photographs available.The syringes were to be used for leuprolide acetate injection.It is unknown if the patient experienced any adverse events and if the product is available for return.
Additional Manufacturer Narrative
Per our investigation: there have been no similar confirmed complaints for this product in the past year visual inspection was performed on 100pcs retained samples with no bent needles observed after opening the needle cap magnified inspection (20x) was performed on 50pcs retained samples with no bent needles observed.Review of in process records did not find any nonconformities relating to bent needles.Potential causes but cannot be confirmed due to the lack of the returned product: mishandling, needle reuse, incorrect cap removal, defects in production process.Based on the available information, the root cause cannot be confirmed.(b)(4).

• Brand Name: EXEL 1/2ML INS SYR 28GX1/2"
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach CA 90278
• Manufacturer Contact: vu doan ; 2500 santa fe avenue; redondo beach, CA 90278 ; 3106490707
• MDR Report Key: 19291790
• Report Number: 1035907-2024-00021
• Device Sequence Number: 21074270
• Product Code: FMF
• UDI-Device Identifier: 00020221260243
• UDI-Public: (01)00020221260243
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K861153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 26024
• Device Lot Number: 210822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown