MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SYRINGE WITHOUT NEEDLE; SYRINGE, PISTON

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation - materials management- msc(whtr) pgdip rn iiwc.The actual sample was not available for evaluation.We could not identify the root cause of the problem based on our investigation of all the available information regarding this issue.There is no evidence that there was a pre-existing defect with the device related to either the materials or the manufacturing process.Retention samples were visually inspected and confirmed free from cracks, deformity, scratch, and melted body.Our barrel complies with iso 80369-7 for the requirements of the design and functional performance of small-bore connectors intended to be used for connections in hypodermic applications of medical devices and accessories.Our molding machine has validated parameters which are checked during the start-up operation of each lot.The molded barrel used to this lot conforms to the inspection criteria based on our records.We have a visual in-process inspection at the boxing process conducted every hour to check the condition of the assembled syringe.Prior to shipment, qc conducts outgoing inspection for molding status of the barrel and assembled syringe condition.No nonconformity such as crack or damage that could lead to a defect similar to the complaint.The retention samples are free from crack or damage.Our syringe assembly process has a barrel tip inspection system that can detect and automatically kick out cut, bent, deformed tip.Lot history file showed no related trouble or nonconformity that could lead to the complaint.Our products are not subjected to any excessive external force during manufacturing.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (b)(4) corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that when the involved device was connected to the customer for saline flush the syringe broke off into the hemocatheter.It required forceps to remove the syringe.There is a potential for an infection and there is damage to the hemocatheter.Additional information was received on 01 mar 2022: the date of event date regarding the syringe tip breaking off during saline flush and retained inside hemocatheter happened over 2-3 days before we were notified of the issue by staff feb 14-16th.The patient procedure is unknown during this time frame.The issue was resolved during the procedure once the tip was removed from the patient's central venous catheter, another brand of a syringe was used to continue the process of connecting the hemodialysis lines to the central line.The patient condition was stable.There was no patient injury when the issue occurred.But there was a potential for injury with possible air emboli from air being able to leak from loose connection and potential for being unable to use the catheter and patient being unable to get lifesaving dialysis treatment.Additional information was received on 04 mar 2022: the characteristics of the breakage was a broken tip.The flushing was not done during the time of the event.The syringe was being connected to the central line at time of breakage for at least 2 of the cases.It was reported that resistance or force shouldn't be related to the cause of the breakage.There was no resistance or difficulty during the connection of the syringe to the port.The staff said that the syringe was loose in the catheter port and that caused some of the concerns, as it didn't fit tightly, they were worried about air leakage around the tip into the patient.The tip of the syringe broke.There was no needle breakage.The needle had already been removed from the syringe and was being attached to the central line lumen and the tip broke off in the catheter lumen.The removal of the syringe tip from the port was successful.They were able to remove the syringe tip from the port.

• Brand Name: TERUMO SYRINGE WITHOUT NEEDLE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, ; RP
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13942992
• Report Number: 3003902955-2022-00003
• Device Sequence Number: 14583777
• Product Code: FMF
• UDI-Device Identifier: 34806017511396
• UDI-Public: 34806017511396
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: SS-20S2
• Device Lot Number: 210205B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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
• Patient Sex: Unknown