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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MONOJECT 60 ML SYRINGE SYRINGE, PISTON

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COVIDIEN MONOJECT 60 ML SYRINGE SYRINGE, PISTON Back to Search Results
Lot Number 1220022939
Device Problems Break (1069); Fluid Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Type  No Answer Provided  
Event Description
Patient receiving hydromorphone pca 25 mg/50 ml noticed that syringe was leaking from pump. Nurses changed out pca syringe. Identified that the syringe tip inside the luer-lock had broken off and was causing leak. Pharmacy purchases the hydromorphone 25 mg/50 ml pca syringes from (b)(4). These are compounded in 60 ml monoject (covidien) syringes. Lot number of affected product was 1220022939, expiration 1/18/2021. In (b)(6) 2020, we notified (b)(4) of broken syringe tips on 2 compounded fentanyl 50 ml syringes ((b)(4), lot 1120024201) that were also in the same 60 ml monoject syringes. It appears there may be an issue with the tips of the monoject syringes. Provided photos of the hydromorphone syringe. Will be discussing at our local medication safety committee meeting and providing information to nursing to be aware of issue. (b)(6). Submission id. (b)(4).
 
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Brand NameMONOJECT 60 ML SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COVIDIEN
MDR Report Key12633971
MDR Text Key276884696
Report NumberMW5104621
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 12/04/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/18/2021
Device Lot Number1220022939
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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