MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917352
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
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
During removal of i/o there was more trauma than anticipated.Item was used in the field by the ems paramedic.They replenished their stock from (b)(6).This is where the defective item was pulled from.The team lost the packaging.The broken product was kept per the notes.The yellow hub became detached from the needle and required unnecessary surgery for removal.
Additional Manufacturer Narrative
Qn#(b)(4).A lot number was not reported.The manufacturing dhr file was reviewed based on a potential lot number from sales history.No recorded results of manufacturing issues or anomalies were reported.The customer returned one ez-io needle cannula from 9079-vc-005, ez-io 45mm needle (box of 5).Visual examination revealed the hub was separated from the cannula and there was evidence of adhesive residue on the hub.The proximal end of the cannula and the hub appeared crushed.It appears this damage was a result of removing the device from the patient after the cannula detached from the hub.The outer diameter of the cannula hub was measured to be 0.750 inches which is within the specification requirements of 0.745 - 0.755 inches per cannula hub drawing 5159 rev 13.The outer diameter of the cannula was measured to be 0.072 inches (micrometer: ref-(b)(4)) which is within the specification requirements of 0.071 - 0.073 inches per cannula drawing 1338 rev a.The sample was sent to the supplier site for further investigation.Per the supplier, there is evidence of glue in the cannula hub which can be seen not only with uv light but with the naked eye as well.Reference file "(b)(4) viant investigation" for supplier investigation.Cannula hub drawing 5159 rev 13 and cannula drawing 1338 rev a were reviewed as part of this investigation.The ifu states "do not rock or bend the catheter.Improper technique may cause catheter to break." the 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 01/2021 and is less than 1 year old.Corrective action is not required at this time as the root cause could not be determined.Teleflex will continue to monitor and trend on complaints of this nature.The reported complaint of "ez-io needle cannula is detached" is confirmed.The hub was separated from the cannula and there was evidence of adhesive residue on the hub.The proximal end of the cannula and the hub appeared crushed.It appears this damage was a result of removing the device from the patient after the cannula detached from the hub.The sample was sent to the supplier site for further investigation.Per the supplier, there is evidence of glue in the cannula hub which can be seen not only with uv light but with the naked eye as well.The device history records for the finished good and needle subassembly were reviewed with no evidence to suggest a manufacturing related cause.Per the supplier investigation, the root cause of this complaint is not manufacturing related.The root cause of this complaint could not be determined based upon the information available.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
During removal of i/o there was more trauma than anticipated.Item was used in the field by the ems paramedic.They replenished their stock from burlington ed.This is where the defective item was pulled from.The team lost the packaging.The broken product was kept per the notes.The yellow hub became detached from the needle and required unnecessary surgery for removal.

• Brand Name: EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12245041
• Report Number: 3011137372-2021-00209
• Device Sequence Number: 11568820
• Product Code: FMI
• UDI-Device Identifier: 10801902170641
• UDI-Public: 10801902170641
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K091140
• 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
• Report Date (Section B): 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN917352
• Device Catalogue Number: 9079P-VC-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention