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U.S. Department of Health and Human Services

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

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COVIDIEN 20ML SYR LUER LOCK TIP SYRINGE, PISTON Back to Search Results
Model Number 1182000777
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2021
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. 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 two 20cc syringes have been defective, where propofol has leaked past the plunger. One was discovered before use in a push syringe, and an another one was noticed during use, in a syringe being used on a syringe pump. The customer further confirmed that there wasn't a delay or issue with the treatment, as a result of the reported issue.
 
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Brand Name20ML SYR LUER LOCK 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 Key11456839
MDR Text Key238977886
Report Number1915484-2021-01221
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,health
Reporter Occupation
Type of Report Initial
Report Date 03/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1182000777
Device Catalogue Number1182000777
Device Lot Number028216X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
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

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