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

MAUDE Adverse Event Report: COVIDIEN NC 1535-I EURO BLADE GRDII NEEDLE, SUTURING, DISPOSABLE

  • 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
 

COVIDIEN NC 1535-I EURO BLADE GRDII NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Model Number 31181467
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
 
Event Description
The customer reported an incident within the operating room where a hollow needle came out of one of the holes on the side of the box when it was closed. As a result, the caregiver pricked himself with the needle causing a blood exposure accident. Additional information received from the initial reporter on (b)(6) 2020 stated that this incident is not linked to a problem with the device, but to a problem with the design of the box. The needle did not puncture the material, it passed through a hole (opening) in the box.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNC 1535-I EURO BLADE GRDII
Type of DeviceNEEDLE, SUTURING, DISPOSABLE
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX 22500
Manufacturer (Section G)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX 22500
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key10813205
MDR Text Key215468226
Report Number9612030-2020-02689
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number31181467
Device Catalogue Number31181467
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/09/2020 Patient Sequence Number: 1
-
-