Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 15MM NEEDLE + STABILIZER BX/5 (EU)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL EZ-IO 15MM NEEDLE + STABILIZER BX/5 (EU) Back to Search Results
Model Number IPN033725
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 10/05/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that from inspecting the intraosseous needle set the catheter and the needle are not connected together and the safety cap is disconnected in the pack; high risk of causing needle stick injury.
 
Manufacturer Narrative
(b)(4).The manufacturing dhr files were reviewed.No recorded results of manufacturing issues or anomalies were reported.The customer returned one photo of the sample; pic1_tc 20036674 20036686.Visual inspection of the photo revealed two closed ez-io 15mm needle sets that contained a 15mm needle with its guard removed.Complaint confirmed.The customer returned one ez-io 15mm needle set for evaluation.Visual inspection of the unopened kit confirmed that the needle guard was removed.This failure mode is likely related to the design of the kits packaging.Certificate of compliance certifies that the aforementioned lot meets the lake region medical (viant) quality system requirements and specifications.This product has been manufactured and controlled by lake region medical (viant) in accordance with the fda qsr and iso (b)(4).A review of the certificate of conformance and device history record found that the needle set passed all the release criteria.The device was released in 08/2019 and is approximately 1 year old.A capa is in process to further investigate the issue of the needle cover becoming detached.The complaint of a guard becoming removed from its needle while still in the kit was able to be confirmed by the customer's returned photo and a complaint investigation of the returned sample.The returned unopened kit was confirmed to contain a needle with its guard removed.The likely cause of this complaint is the package design.A capa is in process to further investigate the issue of the needle guard becoming detached.
 
Event Description
It was reported that from inspecting the intraosseous needle set the catheter and the needle are not connected together and the safety cap is disconnected in the pack; high risk of causing needle stick injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EZ-IO 15MM NEEDLE + STABILIZER BX/5 (EU)
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key10755036
MDR Text Key215280715
Report Number3011137372-2020-00237
Device Sequence Number1
Product Code MHC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model NumberIPN033725
Device Catalogue Number9018P-EU-005
Device Lot Number6715162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Date Manufacturer Received11/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-