MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L 12CC R/A CLR TG RES CSYR; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	SY-1231
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "syringe initially sucked in air but later broke off.Apparently, there was already a crack in it." deroyal industries requested return of the product, however it was not available.An investigation has been initiated but is not complete at this time.No further information is available at this time.We will provide follow-up report when more information becomes available.
Event or Problem Description
A user facility reported, "syringe initially sucked in air but later broke off.Apparently, there was already a crack in it.".
Additional Manufacturer Narrative
Deroyal industries requested return of the product, however it was not available.A photo was provided.Deroyal reviewed device history records for the lot associated with the complaint device.No issues were found.An inventory check was performed on 50 syringes and no issues were found.A failure mode and effects analysis (fmea) was reviewed and no updates were needed.Inspections of product are completed before shipping to ensure all manufacturing was completed to specification and that the syringes meet acceptance criteria.No issues were noted.A complaint to sales ratio was conducted from january 2022 to january 2024 and was found to be 0.0018%.Root cause: because the sample could not be returned and no issues were found in the production record review, the root cause could not be determined.Corrective and preventive action: because no root cause was able to be determined, no corrective or preventive actions were taken.An investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: 12CC R/A CLR TG RES CSYR
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer (Section G): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19951302
• Report Number: 3004605321-2023-00005
• Device Sequence Number: 8923311
• Product Code: DXT
• UDI-Device Identifier: 00749756720243
• UDI-Public: 00749756720243
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K920135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: SY-1231
• Device Lot Number: 56069040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/09/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown