MAUDE Adverse Event Report: TERUMO SYRINGE WITH NEEDLE; SYRINGE, PISTON

Model Number N/A

Device Problems Break (1069); Material Puncture/Hole (1504)

Patient Problems Pain (1994); Needle Stick/Puncture (2462)

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier: requested, not provided a2: age or date of birth: requested, not provided a3a: sex: requested, not provided a3b: gender: n/a a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted d4: udi: not applicable e1: phone number: requested, not provided e3: occupation: sales the actual sample is not available instead, a reference photo was received showing an assembled needle connected to the syringe.The protector was broken, and the fragment can be observed inside the blister packaging under the assembled needle.In addition, the cannula is bent parallel to the position of the broken part of the protector.No traces of opening on the visible part of the packaging were observed.However, we cannot confirm the detailed condition of the actual sample based on the provided photo.The retention samples were visually inspected and confirmed free from any damage or irregularities that could lead to the complaint.To further confirm the source of the broken protector with a puncture, a simulation was conducted both in needle assembly and syringe assembly process.Needle assembly simulation: trial 1: intentionally left product at good product ejection.Result: 5/6 sample has a bent needle and protector, and one (1) sample has a crack on the protector, but the needle is not exposed or protruded from the protector.Trial 2: rejected samples from trial 1 were placed at the linear feeder.Result: 1st run: five (5) pieces were kicked out, and one (1) piece was assembled into the syringe.2nd run: five (5) pieces were kicked out, and one (1) piece did not assemble to the syringe.Trial 3: rejected samples (n-6 from trial 1 were alternated with good samples and placed at the linear feeder.Result: five (5) pieces were assembled into the syringe, and one (1) piece resulted in a detached protector (with a crack protector, but not similar with the complaint sample).Trial 4: the protector on simulated samples (n-6) was taken off and was simulated once more at the needle assembly.Result: a bent needle cannot be loaded with a protector.Simulation activity at syringe assembly process: activity 1: intentionally put a stuck-up needle on the needle spindle crown, then run the machine.Results: unable to create similar defect.The stuck-up needle fell on the needle assembly dial.Activity 2: intentionally misalign the needle on the needle spindle crown, then run the machine.Activity 3: intentionally put a stuck- up needle on the needle assembly dial, then conduct machine running.Results 2 & 3: the needle fell on the needle assembly dial.(cannot create damage) activity 4: intentionally bend the needle protector and then assemble it at the needle assembly dial.Activity 5: intentionally puncture the needle protector, exposed the cannula, then conduct the machine running.Results 4 & 5: unable to create similar defect.No damage or crack on the protector.Activity 6: the needle is intentionally stuck between the cover and the hopper.Results: unable to create similar defect.The needle protector has dent mark and white mark only.Activity 7: intentionally protrude the needle on the needle cart, then intentionally bump into the post.Results: unable to create similar defect.The needle protector has white mark only and traces of crack activity 8: intentionally damage the needle protector, then assemble it at the needle assembly dial.Results: almost the same as the ppr sample, but the needle still in good condition.Result: based on the investigation and simulation conducted, a similar defect cannot be created in the syringe assembly process.Needle assembly process conclusion - a simulation was performed to check if a similar defect can be generated.However, only the bent needle and protector were confirmed to be created.Syringe assembly process conclusion - despite of intentional damage to the needle and stuck-up on the assembly machine, it was confirmed that a similar defect cannot be created.Although we were not able to generate defects similar to the complaint both in needle assembly and syringe assembly process.It is confirmed that an isolated occurrence potentially happened in our needle assembly process.Our supplied raw materials undergo incoming inspection which includes visual inspection and verification of certificate of analysis according to the material specification.The supplied cannula (raw material) lots underwent 100% inspection at our cannula inspection process before it was supplied to the needle assembly process.A total of (3) complaints were received related to damaged parts/products (broken protector) from april 2021 to january 29, 2023, in which one (1) case resulted in a needlestick.We also confirm that the identified potential source of defect failure has an alarm system which will trigger the technician to remove the protector at good product ejection.Furthermore, an information dissemination was conducted to provide awareness to our associates.The exact root cause of the complaint cannot be confirmed.Based on the investigation, a potential occurrence may likely to happen if there will be remaining products at the good product ejection.The appearance of the defect samples created during the simulation is not similar to the complaint sample.Our needle assembly has a high protector alarm and uniform pressing force to prevent damage.During syringe assembly, a needle spindle securely attaches the needle to the syringe using a toothed timing belt.This mechanism has been validated and regularly monitored for uniformity and safety.Syringe components, including barrels, plungers, and needles, are provided separately to the assembly process using hoppers.The transfer and movement of molded parts into dials are facilitated by feeders and guides, preventing cracks and scratches.Our product is not subjected to any excessive external force during manufacturing that could lead to a defect similar to the complaint.Before shipment, we have an outgoing inspection for visual and functional testing to check the overall condition of the finished product.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the user was pricked by the protruded cannula from a broken protector.Injury from being pricked by a needle that has pierced the needle cover it is not yet opened.The event occurred pre-treatment.There was no blood loss.There was no impact on the patient.Additional information was received 19 jan 2024: the nursing staff reported she felt pain with a sharp injury.The packaging may be damaged.The nurse who incurred a minor needle stick injury wound was taken with a band aid by the nursing staff.The needle was not used on a patient.The defective product has been disposed by the user we cannot send it back.A photo of the actual sample was received on 18 jan 2024: evaluation of the reference photo revealed that the protector is broken; a fragment of the protector can be seen inside the package.The point of breakage on the protector is parallel to the bent portion of the cannula.

• Brand Name: TERUMO SYRINGE WITH NEEDLE
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 18718558
• MDR Text Key: 336634708
• Report Number: 3003902955-2024-00003
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K023271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SS+05L2138
• Device Lot Number: 230526C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1