MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ NORMAL SALINE SYRINGE; PRE-FILLED SYRINGE

Catalog Number 306546

Device Problems Melted (1385); Unintended Movement (3026)

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

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that saline "shot out from the plunger end" of the bd posiflush¿ normal saline syringe during use, and it was claim the affected area of the syringe was "melted".

Event Description

It was reported that saline "shot out from the plunger end" of the bd posiflush¿ normal saline syringe during use, and it was claim the affected area of the syringe was "melted".

Manufacturer Narrative

Investigation: our quality engineer was unable to verify the reported complaint.Photos or samples are not available for analysis and because no objective evidence of this issue was found during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to verify this complaint as being generated by manufacturing process.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8317911
• MDR Text Key: 137559136
• Report Number: 9616657-2019-00117
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

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: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8232966
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other