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

MAUDE Adverse Event Report: COVIDIEN 3/10CC INS SAFETY SYR 30X5/16 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 3/10CC INS SAFETY SYR 30X5/16 SYRINGE, PISTON Back to Search Results
Model Number 8881511344
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported that he had a faulty insulin syringe where the mechanism would not lock after he used the syringe. He tried multiple times but the locking mechanism would not engage.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3/10CC INS SAFETY SYR 30X5/16
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 Key9774761
MDR Text Key181996539
Report Number1915484-2020-01138
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881511344
Device Catalogue Number8881511344
Device Lot Number927409X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-