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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 35CC PLK BARL 535WOS TECH SYRINGE, PISTON

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COVIDIEN 35CC PLK BARL 535WOS TECH SYRINGE, PISTON Back to Search Results
Model Number 5551777518
Device Problem Material Fragmentation (1261)
Patient Problems Eye Injury (1845); Laceration(s) (1946)
Event Date 11/16/2018
Event Type  Injury  
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 a syringe filled with potting material shattered onto an operator. She was cut on her chest, chin, and in one of her eyes under her safety glasses. Customer stated that the tube is extremely brittle and pieces crack easily. The customer mixes the potting material and fills the empty syringe, then attach the filled syringe to a time/pressure unit to dispense the material in a housing for potting.
 
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Brand Name35CC PLK BARL 535WOS TECH
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
5084524970
MDR Report Key8271771
MDR Text Key133893483
Report Number1915484-2019-01013
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,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5551777518
Device Catalogue Number5551777518
Device Lot Number819150X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/23/2019 Patient Sequence Number: 1
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