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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 6ML LUER LOCK PHARMACY TRAY SYRINGE, PISTON

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COVIDIEN 6ML LUER LOCK PHARMACY TRAY SYRINGE, PISTON Back to Search Results
Model Number 8881516200
Device Problem Contamination (1120)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2020
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; 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 they found a tiny piece of cardboard inside the barrel of the syringe, on the shaft of the plunger. There was no patient harm reported.
 
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Brand Name6ML LUER LOCK PHARMACY TRAY
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX 22500
Manufacturer (Section G)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX 22500
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key10474042
MDR Text Key206794279
Report Number9612030-2020-02594
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 08/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881516200
Device Catalogue Number8881516200
Device Lot Number2011912264
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
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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