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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 20ML SYR LUER LOCK TIP RP SYRINGE, PISTON

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COVIDIEN 20ML SYR LUER LOCK TIP RP SYRINGE, PISTON Back to Search Results
Model Number 8881520657
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problems Irritation (1941); Numbness (2415)
Event Date 03/11/2019
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 states when assisting with a scalene nerve block, the 20 cc syringe broke during injection. The rn was sprayed with local anesthetic (ropivacaine) in the face (eyes and mouth). The syringe was examined and multiple cracks, a broken tip, and a break in the collar around the tip was noticed. The rn rinsed her eye out at the eyewash station and had slight numbness to her lips for about 10-15 minutes after the incident. No further testing or intervention was required.
 
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Brand Name20ML SYR 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
5084524970
MDR Report Key8433820
MDR Text Key139238297
Report Number1915484-2019-01029
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,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881520657
Device Catalogue Number8881520657
Device Lot Number902816X
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 Received03/11/2019
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: 03/19/2019 Patient Sequence Number: 1
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