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: NULL; NEEDLE, HYPODERMIC, SINGLE LUMEN
  • 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
 

NULL; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2022
Event Type  malfunction  
Event Description
It was reported that "after being stuck for a while, the safety device was suddenly released and left exposed leading to abe.The needle was bent and could not stay into implantable port.Use of another needle to resolve issue".No patient injury was reported.
 
Manufacturer Narrative
Other, other text: the device was returned for evaluation.The sample was visually inspected.The gripper was received with the safety mechanism activated and needle exposed.No damage could be observed on the base, but the needle was bent in a direction that was not perpendicular with normal movement of the safety mechanism.Functional testing performed: the needle was pulled back in order to keep inside of the base and verify if it this can be exposed easily; however, no discrepancies were detected the needle was keep firmly inside of the base.Based on investigation and the sample review, it is likely that the unit was damaged once it left the facility.No corrective actions were taken since the complaint was not confirmed.No lot number was provided for performance of a device history record review.E4 is unknown.
 
Manufacturer Narrative
Other, other text: the device was returned for evaluation.The sample was visually inspected.The gripper was received with the safety mechanism activated and needle exposed.No damage could be observed on the base, but the needle was bent in a direction that was not perpendicular with normal movement of the safety mechanism.Functional testing performed: the needle was pulled back in order to keep inside of the base and verify if it this can be exposed easily; however, no discrepancies were detected the needle was keep firmly inside of the base.Based on investigation and the sample review, it is likely that the unit was damaged once it left the facility.No corrective actions were taken since the complaint was not confirmed.No lot number was provided for performance of a device history record review.E4 is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section G)
NULL
MDR Report Key13586306
MDR Text Key288990710
Report Number3012307300-2022-03978
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/05/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-