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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP RP SYRINGE, PISTON

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COVIDIEN 35ML SYRINGE LUER LOCK TIP RP SYRINGE, PISTON Back to Search Results
Model Number 8881535762
Device Problem Material Fragmentation (1261)
Patient Problem No Patient Involvement (2645)
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 the plungers were broken. The plastic pieces were inside of the syringe near the black rubber plunger tip. This was discovered when the customer opened the package.
 
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Brand Name35ML SYRINGE 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 Key9006351
MDR Text Key165233475
Report Number1915484-2019-01083
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 health professional,user faci
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881535762
Device Catalogue Number8881535762
Device Lot Number914765X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2019
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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