MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; FLUSH SYRINGE

Catalog Number 306595

Device Problem Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: four samples were received for evaluation.Breakout force and sustaining force testing results showed they all are within specification.Based on these results the complaint can't be confirmed and a root cause is undetermined.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

It was reported with the use of the bd posiflush¿ normal saline syringe there were 6 occurrences of when the plunger was pushed halfway it could not be pushed forward.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8270576
• MDR Text Key: 133937561
• Report Number: 1911916-2019-00105
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 306595
• Device Lot Number: 8046825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other