MAUDE Adverse Event Report: TERUMO EUROPE N.V K-PACK II NEEDLE 27G & 30G THIN WALL; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	KN-3013RBKT
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.(b)(4).
Event or Problem Description
The user facility reported that there was a red foreign matter was observed in the hub of the involved needle k-pack ii 30gx 1/2''-0,3x12mm-thin wall-short case.There was no harm to the patient.The event occurred pre-treatment.Additional information was received on 19nov2019.One case happened among 90,000 pieces.Additional information was received on 22nov2019.There was no delay, no impact on patient or user.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.The actual device was initially reported to not be available; however, was received for evaluation.A correction to section d4.Unique identifier (udi)# is being provided.The incorrect udi number was inadvertently submitted on the initial report; therefore, the correct udi# is being provided.The actual sample was received for evaluation.Visual inspection revealed a red contamination was found in the hub.To identify this foreign matter, identification through ir was tried; however, it was not possible to remove the red particles from the hub.A flush test was performed.During this test the foreign matter was tried to be removed by flushing the needle with milliq water.Hereafter, the red contamination was gone and there was nothing present in the water.This means that the contamination was soluble in water and it was not embedded into the material.The batch records have been reviewed of 1810040: moulding hub- equipment (machine/mould): nn23/1944; date: (b)(6) 2018-(b)(6) 2018 and (b)(6) 2018-(b)(6) 2018.Needle assembly- date: (b)(6) 2018-(b)(6) 2018 and (b)(6) 2018-(b)(6) 2018.Packaging- equipment: kpiic; date: (b)(6) 2018-(b)(6) 2018.As part of the final inspection process, (b)(4).During none of the production steps described above, a similar defect was observed during production.No deviations or abnormalities related to your complaint were noted during production.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.If this contamination was caused by terumo, the solvent of ivf-m hp would have removed it during use.As the complaint sample was already used, it is likely that this was caused after the injection to the patient.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: K-PACK II NEEDLE 27G & 30G THIN WALL
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO EUROPE N.V; interlueuvenlaan 40; leuven, 3001 ; BE 3001
• MDR Report Key: 9443400
• Report Number: 9681413-2019-00002
• Device Sequence Number: 2167857
• Product Code: FMI
• UDI-Device Identifier: 04987350700063
• UDI-Public: 04987350700063
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K110850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 09/30/2023
• Device Model Number: KN-3013RBKT
• Device Catalogue Number: 2KN3013RBKT
• Device Lot Number: 1810040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYRINGE.