MAUDE Adverse Event Report: SYRINGE PISTON

Device Problem Failure to Advance (2524)

Patient Problem Inflammation (1932)

Event Date 05/01/2019

Event Type  malfunction  

Event Description

During attempted intravitreal injection of avastin ((b)(6) pharmacy; lot: 190319ap; ubd: 07/02/2019) the plunger would not advance and the medication was not able to be administered.A second syringe was then used and injection of the avastin was successful.Because the pt required 2 needle sticks, his eye became quite inflamed the next day which required topical durezol and ilevro.Fda safety report id# (b)(4).

• Brand Name: SYRINGE PISTON
• Type of Device: SYRINGE PISTON
• MDR Report Key: 8616213
• MDR Text Key: 145486738
• Report Number: MW5086695
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 86