MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 15MM NEEDLE SET + STABILIZER(BOX O; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917337
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The needle cover was off the needle while in the package and struck the employee through the package while unopened.
Additional Manufacturer Narrative
(b)(4).The customer returned three photos for evaluation; reference (b)(4).The first photo revealed an opened kit with a loose needle guard and the second photo revealed the product lidstock from which the lot number was able to be confirmed.The third photo revealed puncture holes in the packaging.Complaint confirmed.Based on the customer description and photos returned, this complaint is likely related to package design.Certificate of compliance (part of dhr) certifies that the aforementioned lot meets the viant upland quality system requirements an d specifications.This product has been manufactured and controlled by viant upland in accordance with the fda qsr and iso iso13485:2016.A review of the certificate of conformance/device history record found that the needle set passed all the release criteria.The device was released in 02/2021 and is approximately 0.5 years old.Corrective actions for a capa were implemented in sep 2021.This ez-io kit was manufactured in feb 2021, prior to the corrective actions being implemented.The complaint of a guard becoming removed from its needle while still in the kit was able to be confirmed by the returned customer photos.One photo displayed a loose guard and the other confirmed there were puncture holes from the needle in the packaging.The likely cause of this complaint is the package design.Corrective actions for a capa were implemented in sep 2021.This ez-io kit was manufactured in feb 2021, prior to the corrective actions being implemented.
Event or Problem Description
The needle cover was off the needle while in the package and struck the employee through the package while unopened.
Additional Manufacturer Narrative
(b)(4).The manufacturing dhr file was reviewed.No recorded results of manufacturing issues or anomalies were reported.Certificate of compliance (part of dhr) certifies that the aforementioned lot meets the viant upland quality system requirements and specifications.This product has been manufactured and controlled by viant upland in accordance with the fda qsr and iso iso13485:2016.A review of the certificate of conformance/device history record found that the needle set passed all the release criteria.The device was released in 02/2021 and is approximately 0.5 years old.The complaint sample is not available for return.Functional testing and investigation activities cannot be conducted.The complaint root cause cannot be established.The complaint cannot be confirmed from the customer photo.No corrective/preventative actions will be assigned.The complaint sample is not available for return.Functional testing and investigation activities cannot be conducted.The complaint root cause cannot be established.The complaint cannot be confirmed from the customer photo.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
The needle cover was off the needle while in the package and struck the employee through the package while unopened.

• Brand Name: EZ-IO 15MM NEEDLE SET + STABILIZER(BOX O
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12407039
• Report Number: 3011137372-2021-00230
• Device Sequence Number: 5130878
• Product Code: FMI
• UDI-Device Identifier: 10801902170498
• UDI-Public: 10801902170498
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2021

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: 01/31/2025
• Device Model Number: IPN917337
• Device Catalogue Number: 9018P-VC-005
• Device Lot Number: 7436193
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021; 10/27/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/04/2021; 10/28/2021
• 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: N/A.; N/A.