MAUDE Adverse Event Report: TERUMO EUROPE N.V K-PACK II; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: quality coordinator.The actual device was returned for evaluation.Visual inspection revealed that the glue cone was intact, and there was still a piece of the cannula present in the hub.The cannula broke after administration of the vaccine.Thirteen retention samples of the reported lot number (1706031) were functionally tested for resistance to breakage of the cannula.All the samples were found to be within manufacturer specification.The remaining sixty-one retention samples were visually inspected; no deformities or damages were observed.A review of the batch record of the product code/lot number combination revealed no anomalies.During the needle assembly eight units were measured for cannula bonding once per shift, all functional results comply with the specification.As part of the final inspection process, thirteen units were measured for cannula bonding, and 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.It is likely that accidental manipulation may have caused the reported event.However, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo europe n.V.(manufacturer) registration no.9681413.Exemption number e2015027.
Event or Problem Description
The user facility reported that the that the involved k-pack cannula was detached from the hub of the needle during use.The patient was not harmed; no information was reported about patient harm.Additional information was received on april 4, 2019.The needle was used with a slip tip syringe.The vaccine was boostrix.The type of damage was detachment without breakage or cutting of the cannula.The injection was already performed; before the reported event occurred, the cannula detached after complete administration of the vaccine.It was reported that the user did not have the information in regards to whether the cannula detached while being in the patient or outside of the patient.It is unknown how the cannula was removed from the patient; if it was detached in the patient.

• Brand Name: K-PACK II
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO EUROPE N.V; interlueuvenlaan 40; leuven 3001 ; BE 3001
• MDR Report Key: 8544620
• Report Number: 9681413-2019-00001
• Device Sequence Number: 367864
• Product Code: FMI
• UDI-Device Identifier: 05413206032648
• UDI-Public: 05413206032648
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K984576
• 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): 04/24/2019

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: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: KN-2525RB04
• Device Lot Number: 1706031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/24/2019
• 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: SLIP-TIP SYRINGE