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

MAUDE Adverse Event Report: COVIDIEN 20ML SYR LUER LOCK TIP RP SYRINGE, PISTON

  • 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 20ML SYR LUER LOCK TIP RP SYRINGE, PISTON Back to Search Results
Model Number 8881520657
Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2020
Event Type  malfunction  
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
Per customer, the patient was in training to do hemodialysis at home. In the training room, when the patient has connected a blunt fill needle to the syringe to draw normal saline into syringe, there was leaking noticed around the tip. The staff member was asked to see the syringe and an abnormality in the syringe was noticed. Upon looking closer, the syringe tip was noted to be missing from the inside threads. The patient did not use the product. There was no patient harm reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name20ML SYR LUER LOCK TIP RP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer (Section G)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key11216710
MDR Text Key228435956
Report Number1915484-2021-01202
Device Sequence Number1
Product Code FMF
UDI-Device Identifier20884521012155
UDI-Public20884521012155
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881520657
Device Catalogue Number8881520657
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-