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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 1/2CC E100 SAF 29X1/2 SYRINGE, PISTON

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COVIDIEN 1/2CC E100 SAF 29X1/2 SYRINGE, PISTON Back to Search Results
Model Number 8881511136
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 safety lock is not good, and it does not lock properly. The issue was discovered when the needles were tested after opening the box. There was no patient involved.
 
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Brand Name1/2CC E100 SAF 29X1/2
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 Key11680441
MDR Text Key247931594
Report Number1915484-2021-01231
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 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881511136
Device Catalogue Number8881511136
Device Lot Number033918X
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 Received04/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2000
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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