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


  • 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

Catalog Number CLGY-2034
Device Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2017
Event Type  malfunction  
Manufacturer Narrative
One sample of product, clgy-2034 with an unknown lot #, was returned for evaluation. The complaint is confirmed to have the needle protruding through the safety cap. Visual inspection revealed that the needle is protruding through the yellow base. Both the track and base for the protective housing of the needle appears to be loosely seated on top of the white wings. The notch in the vertical part of the wings is not flush against the back part of the yellow tracks. The ifu instructions state that using your dominant hand grasp the flexible wings and pull upward until the needle is completely encapsulated in the needle trap. The ifu instructions state that during removal the user should have visual confirmation that the needle trap completely encapsulates the needle. The user should also hear it lock into the safe position. When following the removal/disposal instructions on the returned device, the complaint investigator confirmed the needle was visually and audibly locked into place in the safe position. The needle is observed to be encapsulated properly with no exposed needle sticking out of the base. The white notch of the wings is flush with the back of the yellow tracks. A review of the lot history record could not be conducted for this product since the lot # was not provided. All production and qc personnel are up to date with their training. The review of the production and quality control procedures revealed an acceptable inspection criterion. The procedure records the necessity of the products to be visually inspected under normal industrial lighting at a distance of 12" to 18". The product is inspected for missing, extra, deformed, or misassembled components. There are no documented issues known that would have contributed to this type of complaint. The root cause for the reported complaint of an exposed needle that could be a potential needle stick hazard is improperly securing the used needle after removal. Instructions on how to secure the used needle prior to disposal were not followed. In reviewing this issue, it was noted that this is the first occurrence for the exposed needle that is a potential needle stick hazard within the last 3 years.
Event Description
Safety malfunction: the needle protrudes through the safety cap which is a potential hazard to the nurse handling the needle for risk of being stuck by a contaminated needle.
Manufacturer Narrative
Please see mdr 2245270-2017-00031 for data for an additional occurence of this malfunction with this customer. The malfunctioning device was returned to vygon for evaluation as part of the complaint investigation. The results of this investigation are still pending and will be communicated to fda within thirty days of its conclusion via follow-up mdr.
Event Description
Safety malfunction: the needle protrudes through the safety cap which is a potential hazard to the nurse handling the needle for risk of being stuck by a contaminated needle.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
87 venture drive
dover NH 03820
Manufacturer (Section G)
87 venture drive
dover NH 03820
Manufacturer Contact
freda lacroix
2750 morris road
lansdale, PA 19446
MDR Report Key6661746
MDR Text Key196700035
Report Number2245270-2017-00030
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCLGY-2034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial