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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation-qa team.The actual sample was received for evaluation.The received complaint sample had a broken cannula.The point of breakage is at the end of the glue cone.This is the weakest point of the cannula if pressure is applied to the needle.Since the initial complaint information describes that the cannula broke off after injection to the patient, the cannula was not broken before use on the patient.Based on our experience we believe that the user probably induced breakage, by severely bending the needle and bringing it back to its original position.The batch record for 2kn3013rbkt (lot 1808020) has been reviewed; needle assembly equipment: (b)(4).Date: 11/10/2018-14/10/2018.Needle assembly equipment: (b)(4).Date: 13/03/2018-15/03/2018.Packaging equipment: (b)(4).Date: 11/10/2018-15/10/2018.During production, as an in-process control, twice per shift (approximately every 4 hours), 40 needles are visually inspected for among others things for damage to the cannula.No damage to the cannula was found for the batch noted above.Thirteen (13) retention samples of lot 1808020 were visually inspected to determine damage or bent needles.No defects were found.Additionally, 13 retention samples were tested for their resistance to breakage.All samples were within specification.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.As no abnormalities were reported in the batch record and the inspected retention samples were all visually free from damage and showed no out of specification for the resistance to breakage test, no root cause related to our production activities could be determined.We advise the customer not to bent the cannula.(b)(4).
Event or Problem Description
The user facility reported that there one of two elrabie premier light-lc needles envelope was crooked and bent during the procedure (injection) and eventually came off the hub.The other needle was fine.Additional information was received 05january2020: patient condition: seems to be no impact on the patient.Additional information was received 17january2020: the procedure outcome was completed successfully with no delay.There was no impact on the patient or user.Patient was not harmed.It was told by the user that the needle became bent and was broken but it did not remain in the skin.Also, it did not leave any wound, edema or pain on the patient's face.During the procedure, the needle became bent and broke, it fell off the hub, and did not remain in the skin.During the procedure, as the needle broke, the doctor opened another needle and the patient was not shaken.Elrabie premier light-lc: cross-linked sodium hyaluronate 23 mg/ml is the main ingredient of the product, which is used for wrinkle-enhancement and has a viscosity of 25~35pa.S.

• 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: 9661441
• Report Number: 9681413-2020-00001
• Device Sequence Number: 17012990
• Product Code: FMI
• UDI-Device Identifier: 05413206051045
• UDI-Public: 05413206051045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/03/2020

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: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: KN-3013RBKT
• Device Lot Number: 1808020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1