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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MONOJECT SYRINGE, PISTON

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COVIDIEN MONOJECT SYRINGE, PISTON Back to Search Results
Model Number 8881511136
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2018
Event Type  malfunction  
Manufacturer Narrative
Submit date: 4/26/2018. 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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states that the client took home box of needles to give pet insulin and 1 of the needles fell off before use and the client was unable to find needle until a few days later when she stepped on it and punctured her toe. No medical attention was required.
 
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Brand NameMONOJECT
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
1222 sherwood rd
norfolk NE 68701 9062
Manufacturer (Section G)
COVIDIEN
1222 sherwood rd
norfolk NE 68701 9062
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key7465706
MDR Text Key106712177
Report Number1915484-2018-00024
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 distributor
Reporter Occupation
Type of Report Initial
Report Date 04/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881511136
Device Catalogue Number8881511136
Device Lot Number725120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2018
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 Unkown

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