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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 1ML TB SYR 25G X 5/8 DETACH RP; SYRINGE, PISTON
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COVIDIEN 1ML TB SYR 25G X 5/8 DETACH RP; SYRINGE, PISTON Back to Search Results
Model Number 8881501160
Medical Device Problem Codes Nonstandard Device (1420); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional 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 or Problem Description
The customer reported that the syringes are not holding vacuum and the expiration date could not be located on the product.There was no patient harm.
 
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Brand Name
1ML TB SYR 25G X 5/8 DETACH RP
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key9799970
Report Number1915484-2020-01141
Device Sequence Number14204002
Product Code FMF
UDI-Device Identifier20884521013954
UDI-Public20884521013954
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/06/2020
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 Number8881501160
Device Catalogue Number8881501160
Device Lot Number929480X
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/03/2020
Initial Report FDA Received Date03/06/2020
Patient Sequence Number1
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