MAUDE Adverse Event Report: CAP; SYRINGE, PISTON

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2020

Event Type  malfunction  

Event Description

Single use caps on prefilled syringes can be removed without breaking them as designed allowing the cap to be reused.The syringe contents can be adulterated or diverted without detection.Fda safety report id# (b)(4).

• Brand Name: CAP
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 10086855
• MDR Text Key: 192206629
• Report Number: MW5094668
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 91