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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE CATHETER TIP SYRINGE, PISTON

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COVIDIEN 60ML SYRINGE CATHETER TIP SYRINGE, PISTON Back to Search Results
Model Number 1186000444
Device Problems Fluid Leak (1250); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2020
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; 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.   if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported that there was resistance when flushing the peg tube. The contents of the syringe escaped out at the back of the barrel after passing around the plunger tip. The customer further added that the plunger was not sealed with the barrel. There was no injury to the patient or staff.
 
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Brand Name60ML SYRINGE CATHETER TIP
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 Key9808472
MDR Text Key183252630
Report Number1915484-2020-01142
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
Report Date 03/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1186000444
Device Catalogue Number1186000444
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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