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U.S. Department of Health and Human Services

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

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COVIDIEN 20ML SYR LUER LOCK TIP RP SYRINGE, PISTON Back to Search Results
Model Number 8881520657
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event Description
The customer reported that when they were mixing the drugs a small piece of plastic was noticed inside of the syringe. There was no patient harm reported.
 
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Brand Name20ML SYR LUER LOCK TIP RP
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 Key11003859
MDR Text Key221531035
Report Number1915484-2020-01199
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
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 03/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881520657
Device Catalogue Number8881520657
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 Received11/24/2020
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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