• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET

  • 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
 

GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2426-0007
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. The customer's address is unknown:  (b)(6) has been used as a default.   device manufacture date: unknown. Investigation summary: a complaint of a discolored spike was received from the customer. No product or photo was returned by the customer. The customer complaint of discoloration could not be verified due to the product not being returned for failure investigation. A device history record review could not be performed on model 2426-0007 because a lot number was not provided by the customer. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: due to no sample being received, an investigation could not be performed and a root cause could not be determined. No product will be returned per customer. No investigation was performed.
 
Event Description
It was reported that the gem 20dp ckv 3ss dehp free experienced foreign matter in fluid pathway. The following information was provided by the initial reporter: this is a separate issue from previously reported problems with the spike in the past, centered specifically on discoloration and contamination of the spike.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGEM 20DP CKV 3SS DEHP FREE
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12351674
MDR Text Key267645844
Report Number9616066-2021-51862
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 08/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-