MAUDE Adverse Event Report: BD BD POSIFLUSH; 0.9% NACL PREFILLED 10ML SYRINGE

Catalog Number 8290-306546

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2014

Event Type  malfunction  

Event Description

The overwrap from a prefilled bd syringe of a 0.9% nac1 is torn therefore exposing syringe.The product now is not tamper proof.Amount: 0.9% nac1 syringe, frequency: prn/as needed, route: intravenous.

• Brand Name: BD POSIFLUSH
• Type of Device: 0.9% NACL PREFILLED 10ML SYRINGE
• Manufacturer (Section D): BD
• MDR Report Key: 3833666
• MDR Text Key: 18568296
• Report Number: MW5036217
• Device Sequence Number: 1
• Product Code: NGT
• 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: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 8290-306546
• Device Lot Number: 4041170
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2014
• Patient Sequence Number: 1
• Patient Age: 1 DA