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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UNKNOWN SYRINGE SYRINGE, PISTON

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COVIDIEN UNKNOWN SYRINGE SYRINGE, PISTON Back to Search Results
Model Number 1183500777
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/06/2020
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
The customer reported a monoject 35 ml syringes with an unknown product code was bought pre-filled by pharmacy but once it was brought to the unit, it was discovered to be broken. This issue is causing the hospital to waste quite a bit of fentanyl. Additional information was received on 28-apr-2020 stating that leaking was noticed during priming.
 
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Brand NameUNKNOWN SYRINGE
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 Key10017248
MDR Text Key191716913
Report Number1915484-2020-01160
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
Report Date 07/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1183500777
Device Catalogue Number1183500777
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 Received04/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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