MAUDE Adverse Event Report: BD BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number 306547

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 08/21/2019

Event Type  malfunction  

Event Description

Attempting to flush saline lock and it was noted that the plunger on the prefilled saline flush was resistant and difficult to push.Disconnected the syringe from the saline lock and attempted to push fluid out of syringe.With the syringe not connected to anything it was noted to be extremely difficult to push the plunger of the prefilled saline syringe, even with extreme force.

• Brand Name: BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD; 5859 farinon dr ste 200; san antonio TX 78249
• MDR Report Key: 9086237
• MDR Text Key: 159134690
• Report Number: 9086237
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2019

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: Health Professional
• Device Model Number: 306547
• Device Catalogue Number: 306547
• Device Lot Number: 9115986
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 65