MAUDE Adverse Event Report: SYRINGE; SYRINGE, PISTON

Lot Number 0339309

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous; patient reported was mixing and the syringe popped off when inserting the second syringe with 50ml.Cassette lot number 3971696, expiration date 06/17/2025; syringe lot number 0339309, expiration date unknown.No harm to patient.No interruption in therapy.Unknown if product available for return.No further information provided.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? no; did we [mfr] replace the device? yes; did the pt have a backup device they were able to switch to? yes; was the pt able to successfully continue their infusion? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: SYRINGE
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 12662641
• MDR Text Key: 277682797
• Report Number: MW5104756
• Device Sequence Number: 2
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0339309
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1