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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UNKNOWN NEEDLES AND SYRINGES SYRINGE, PISTON

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COVIDIEN UNKNOWN NEEDLES AND SYRINGES 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 04/23/2020
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 that a monoject 35 ml syringe with an unknown product id and lot number was being filled by their onsite pharmacy and upon use, they found the tip had broken off. The customer further stated that this issue is causing the hospital to waste quite a bit of fentanyl. Additional information provided stated that leaking was noticed during priming. The customer also stated that the pharmacy did not encounter any issue while they were filling the syringe. The issue was only noticed once it was on the unit.
 
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Brand NameUNKNOWN NEEDLES AND SYRINGES
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 Key10017220
MDR Text Key191717738
Report Number1915484-2020-01159
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 07/08/2020
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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