MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA K-PACK II; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	KN-2525RB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone number: unknown e3: occupation: unknown h6: investigation findings - code 3211 is based upon the evaluation of user facility information and the investigation of the photo; code 213 is based upon functional testing of the retention samples.A picture of the complaint sample was provided.The photo shows the cannula detached from the hub.The cannula is still intact and not broken.The white spot visible on the cannula is glue.On 16/12/2025 it was confirmed that the cannula got detached from the hub after application of the product and the product being withdrawn from the muscle.Broken product is considered major defect according to cps-1001 (aql 0.4).On 12/12/2025 we received confirmation that the complaint sample could not be returned for further investigation.Batch record review (device history record).Since the gluing process step occurs at the needle assembly lines the investigation is focused on the needle assembly process.The following tests are performed on the product during production of each lot: 1.The glue cone is visually inspected in-line for all products.The correct working of this in-line inspection is challenged once per day by placing a dummy needle in front of the inspection.2.During in-process control in needle assembly, 40 pieces are visually inspected twice per shift for foreign matter or excessive glue on the cannula or hub.Semi-finished products were visually inspected by the process inspector by removing the case.3.2 pieces per shift are functionally tested for penetration resistance and 11 pieces per shift are functionally tested for bonding strength of the cannula to the hub.4.During in-process control in k-pack assembly, 40 pieces of needles are visually inspected twice per shift.Furthermore, a final visual inspection is performed on 1250 pieces before sterilization.If any abnormalities are observed during any of these inspections, a non-conformity is raised.Sample investigation: not returned.Retention samples: all retention samples were visually inspected.No similar defects or defects related to glue issues were observed.Production investigation: in the needle assembly process a hub is placed on a jig.A jig is a metal part which fits into the taper of the hub and is used to transport the hub through the needle assembly machine.In a next step a cannula is placed into the hub shaft after carefully aligning and by gravity.The next step is the gluing process.Glue is supplied from a glue pump and piping system which fills a glue disc with a certain amount of glue.A hub with cannula is placed in front of a rotating glue disc.The cannula is held upwards by a red belt, and the hub is placed downwards by lowering the jig in a guidance rail.The cannula touches the glue on the side of the glue disc and by adherence characteristics and centrifugal forces a certain glue amount (item dependant) is transferred from the disc to the cannula.In the trajectory before the oven, the jig with hub, glue and cannula will vibrate within the guiding rails to evenly distribute the glue and form the glue cone.The curing takes place in the oven.Next process steps are not relevant for this complaint.The amount of glue on the glue disc is supplied by a glue pump that is providing a continuous amount of glue onto the glue disk, and it is controlled by a doctor that will scrape off excess amount of glue.Typically, the glue string ranges from a few millimetres above the glue cone to no string above the cone.In figure 3 a detail is shown of the application of the glue with the glue disk.The length of the glue string above the glue cone is dependent on the height of the disk, the depth of the hub on the jig and the height of the red belt holding the cannula during gluing.It's the combination of these variables that will determine the amount of glue and the location of the glue.In case a lower amount of glue is applied at a higher location, there is a risk of no glue run trough inside of the hub and thus a risk of cannula not bonding to the hub.During the assembly process on na07 notifications were made by the operator and technician related to the finetuning of the glueing station.Possibly the complaint sample was produced during this time, but this cannot be confirmed.After the needle assembly process the products (hub+ cannula) leave the production line covered by a case, which protects the cannula and hub from any foreign matter.During packaging, a cap is placed on the assembled needle, and a label applied.The complaint database was reviewed.From fy22 until fy25 one other complaint was registered with failure mode cannula loose.But here no clear pictures of the defect were provided thus this is considered unrelated to the currently observed defect.From the batch record review, retention sample investigation no deviations or abnormalities were noted during production related to your complaint.Based on the visual inspection of the complaint sample and the production investigation we confirm the complaint to be production related.However, the low complaint rate indicates that the risk for the occurrence of this defect is low and that no immediate actions are required at this point; this complaint will be shared with the production team and maintenance team to stress the importance of correct setting of the glue.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo europe n.V.(manufacturer) registration no.9681413.
Event or Problem Description
Terumo received the reported information.On 05nov2025, pictures of the finished product (fp) batch lx4202 (f000042606), were visually checked.It was noticed that the needle was broken off the needle hub.There was no patient injury, and no medical or surgical intervention was required.The final patient impact and procedure outcome were unknown.Additional information was received on 16dec2025: the metal needle detached from the cone while being withdrawn from the muscle after application.

• Brand Name: K-PACK II
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya-shi, shizuoka 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 23906532
• Report Number: 9681413-2025-00007
• Device Sequence Number: 13267857
• Product Code: FMI
• UDI-Device Identifier: 05413206003815
• UDI-Public: 05413206003815
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K984576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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: KN-2525RB
• Device Catalogue Number: KN-2525RB
• Device Lot Number: 2407018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SYRINGE TO INJECT VACCINE
• Patient Sex: Unknown