MAUDE Adverse Event Report: UNKNOWN MONOJECT 35ML BARREL ASSEMBLY SYRINGE; INSTRUMENT, SURGICAL, DISPOSABLE

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

We have 2 reports of cracked syringes related to our pharmacy prepared patient-controlled analgesia.The syringe in use is a monoject 35 ml barrel assembly syringe purchased through cardinal.Lot number: 2215809964, expiration date: 5/31/2027.The first event noted a syringe tip being broken off upon nurse administration.The second event noted a cracked and leaking syringe, yet further details of the location of the crack was not noted.Cardinal has been notified and will be notifying the manufacturer.Reference report: mw5146334.

• Brand Name: MONOJECT 35ML BARREL ASSEMBLY SYRINGE
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17853835
• MDR Text Key: 324843724
• Report Number: MW5146335
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1