MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE S2 NS 20ML; SALINE FLUSH

Catalog Number 309210

Device Problem No Pressure (2994)

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

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported bd syringe s2 ns 20ml was found to have foreign matter inside the syringe prior to use.The following information was provided by the initial reporter: verbatim: ¿ there is dirt/ particles inside the 20ml syringe (component 309210) in the set.".

Manufacturer Narrative

H.6.Investigation: bd has been provided with photos and a sample for catalog 309210 lot 9071807 to investigate for this record.Visual examination of the photos and sample shows the white particles in the syringe and have determined that they are composed by lubricant from the syringe barrel.As a result, bd was able to verify the reported issue.Bd has concluded that the mentioned ¿particles¿ consist of accumulation of ¿slip agent¿ which is used in the formulation of the polypropylene which is in turn used to manufacture the syringe.This slip agent is used to facilitate the movement of the plunger along the barrel.During the manufacturing process, the lubricant forms a microscopic layer in the internal/external walls of the barrel.When the plunger is moved backwards during the filling of the syringe, most of this microscope layer of lubricant is dragged behind the plunger and a small quantity still remains inside to allow a good sliding performance during the injection operation.Toxicologic material risk assessment test were completed and all tests passed and met all established criteria for preclinical toxicological safety evaluations.Based on the evaluation conducted, it is concluded that the reported white particles are inherent to the product design and material and should not represent any risk if the product is used according to the normal clinical practices.The device history review showed no indication of the alleged defect.

Event Description

It was reported bd syringe s2 ns 20ml was found to have foreign matter inside the syringe prior to use.The following information was provided by the initial reporter: verbatim: ¿ there is dirt/ particles inside the 20ml syringe (component 309210) in the set.".

• Brand Name: BD SYRINGE S2 NS 20ML
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 9751980
• MDR Text Key: 193098906
• Report Number: 3002682307-2020-00064
• Device Sequence Number: 1
• Product Code: NGT
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/29/2024
• Device Catalogue Number: 309210
• Device Lot Number: 9071807
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other