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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP SYRINGE, PISTON

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COVIDIEN 35ML SYRINGE LUER LOCK TIP SYRINGE, PISTON Back to Search Results
Model Number 1183500777
Device Problems Break (1069); Fluid Leak (1250)
Patient Problems High Blood Pressure/ Hypertension (1908); No Information (3190)
Event Date 05/09/2020
Event Type  Injury  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation because it was discarded; 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 tip of a fentanyl pca syringe was broken off inside the pca tubing. The patient was required titrating up other sedation gtts on previous shift. This syringe was not prefilled by cardinal health. Additional information was provided stating that additional doses of anti-hypertensives were also given because of the lack of sedation. They also stated that there was leaking, however, the propofol was backing up into the fentanyl infusion tubing and it took multiple hours to finally figure out it was leaking as the fentanyl was going at a very slow ml/hr rate and it was not obvious that there was a leak. The patient's current status is unknown.
 
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Brand Name35ML SYRINGE LUER LOCK TIP
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 Key10116598
MDR Text Key193917872
Report Number1915484-2020-01170
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1183500777
Device Catalogue Number1183500777
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 Received05/12/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/03/2020 Patient Sequence Number: 1
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