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

Lot Number 1120024201

Device Problems Break (1069); Fluid/Blood 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).

• Brand Name: MONOJECT 60 ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12633971
• MDR Text Key: 276884696
• Report Number: MW5104621
• Device Sequence Number: 2
• Product Code: FMF
• UDI-Device Identifier: 70004020022
• UDI-Public: 70004-020022
• Combination Product (y/n): Y
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 1120024201
• Patient Sequence Number: 1