MAUDE Adverse Event Report: BD BD 20ML SYRINGE; SYRINGE, PISTON

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

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

Event Date 05/25/2019

Event Type  malfunction  

Event Description

Syringe packaging not sealed, therefore syringes not sterile.Forced to waste iv products prepared due to lack of sterility.Only two strips of syringes noted to have this issue, other syringes in box appeared sealed.Abnormal packaging (black strip) noted.

• Brand Name: BD 20ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 8655322
• MDR Text Key: 146670812
• Report Number: MW5087003
• Device Sequence Number: 2
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 05/26/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1