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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON
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COVIDIEN 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON Back to Search Results
Model Number 8881512258
Medical Device Problem Code Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Additional 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 or Problem Description
Customer reports: one of the syringes has free floating particles.
 
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Brand Name
12ML LUER LOCK TIP PHARM TRAY
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key11728091
Report Number9612030-2021-02877
Device Sequence Number14420241
Product Code FMF
UDI-Device Identifier10884521010970
UDI-Public10884521010970
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number8881512258
Device Catalogue Number8881512258
Device Lot Number2030104764
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/22/2021
Initial Report FDA Received Date04/26/2021
Patient Sequence Number1
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