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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

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COVIDIEN 60ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON Back to Search Results
Model Number 1186000777
Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 05/02/2019
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 reports the luer tip of the syringe was missing and damaged.
 
Manufacturer Narrative
The manufacturing site received two pictures from the customer.Visual examination of these pictures suggests that the tip is missing from the syringe.The reported condition was confirmed and is classified as a malformed, flash, short shot or damage that would impair function.The device history record (dhr) for the lot control and the shop orders indicate that product and specification requirements were met with no non-conforming product identified relating to this customer report.From the picture it can be confirmed that the tip is not present, but without a physical sample a more definitive root cause cannot be determined at this time.Control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, assembly, and packaging processes, and to ensure components and finished product meet all quality inspection standards during the syringe assembly processes.Based on the information available and the investigation findings, a corrective and preventive action (capa) is not deemed necessary at this time.
 
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Brand Name
60ML SYRINGE LUER LOCK TIP
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701
MDR Report Key8607372
MDR Text Key145032731
Report Number1915484-2019-01051
Device Sequence Number1
Product Code FMF
UDI-Device Identifier10884521010864
UDI-Public10884521010864
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/26/2019
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
Device Operator No Information
Device Model Number1186000777
Device Catalogue Number1186000777
Device Lot Number900131X
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/02/2019
Initial Date FDA Received05/14/2019
Supplement Dates Manufacturer Received05/02/2019
Supplement Dates FDA Received09/26/2019
Patient Sequence Number1
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