MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE

Catalog Number 306595

Device Problem Leak/Splash (1354)

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

Event Date 12/05/2019

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 a damaged barrel was found before use with a 10 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter, "the flush(10ml) was found to have a very large crack in the barrel when it was opened for use.".

Manufacturer Narrative

H.6.Investigation summary: one sample was received.It has no packaging flow wrap.It has plunger rod-rubber stopper, tip cap, saline solution and barrel label.The barrel and barrel flange are damaged therefore failure mode is verified.This damage may have happened at the diverter which is located right before the packaging flow wrapper.A jam at the diverter could have induced this damage and not been noticed during the packaging process.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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.H3 other text : see section h.10.

Event Description

It was reported that a damaged barrel was found before use with a 10 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter."the flush(10ml) was found to have a very large crack in the barrel when it was opened for use.".

• Brand Name: 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9525781
• MDR Text Key: 193677803
• Report Number: 1911916-2019-01338
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 306595
• Device Lot Number: 9113975
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other