MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ SYRINGE; PISTON SYRINGE

Catalog Number 301942

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

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 when using the bd¿ syringe there was foreign matter on device cannula/needle/syringe or any fluid path component.The customer stated 1200 devices were affected.The following information was provided by the initial reporter and translated to english.The customer stated: the "nurse opened the package and while pushing and pulling the syringe, the nurse saw a white ring.Inside the syringe a white circle moved back and forth with plunger movement at the rod head.At least 7 out of 10 syringes had this issue.".

Event Description

It was reported when using the bd¿ syringe there was foreign matter on device cannula/needle/syringe or any fluid path component.The customer stated 1200 devices were affected.The following information was provided by the initial reporter and translated to english.The customer stated: the "nurse opened the package and while pushing and pulling the syringe, the nurse saw a white ring.Inside the syringe a white circle moved back and forth with plunger movement at the rod head.At least 7 out of 10 syringes had this issue.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/16/2021.H.6.Investigation: a device history record review was performed for provided lot number 2104162 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, a shelf carton of product was returned for evaluation by our quality engineer team.Through examination of the returned samples, white particles were noticed within the syringes.We have concluded that the particles are composed of the slip agent used in the manufacture of this syringe product.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 microscopic 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.This is a normal process and the syringe would not work without the presence of this lubricant.The most restrictive food additives regulations from different countries allow a maximum level of 0.2 % of lubricant.The specification for the quantity of lubricant used in the barrel of bd two piece syringes is below this limit.A toxicologic material risk assessment for the slip agents used in bd discardit ii 2-piece syringes indicate an extremely low to negligible risk of adverse effect in this clinical application.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.20 retained samples of the reported issue and no defect was observed.

• Brand Name: BD¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12694171
• MDR Text Key: 278351202
• Report Number: 3002682307-2021-00575
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301942
• Device Lot Number: 2104162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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