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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 101 S-RX TB SP BULK SYRINGE, PISTON

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COVIDIEN 101 S-RX TB SP BULK SYRINGE, PISTON Back to Search Results
Model Number 8881101011
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Retinal Injury (2048)
Event Type  Injury  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported that the syringe caused a hole in the retina. Additional information was provided on 13-jan-2021 stating that the patient was undergoing a vitrectomy and when the doctor was injecting balanced salt solution (bss) with the tuberculosis (tb) syringe it was difficult to press the plunger requiring force which caused a hole in the patient¿s retina. Additional information received on 26-jan-2021 stated that the patient did not require treatment above or beyond what occurred in the originally scheduled procedure. She further stated that the her best estimate is that the incident occurred between (b)(6) 2020. Patient's current status: no adverse outcomes were reported from the scheduled procedure.
 
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Brand Name101 S-RX TB SP BULK
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 Key11247900
MDR Text Key229304720
Report Number1915484-2021-01203
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,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881101011
Device Catalogue Number8881101011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
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 Unkown

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