MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 10ML E/T

Catalog Number 302146

Device Problem Leak/Splash (1354)

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

Event Date 03/18/2024

Event Type  malfunction  

Event Description

It was reported that bd syringe 10ml e/t had foreign matter the following information was provided by the initial reporter: sealed syringe packet, however dirty syringe with brown substance evident inside.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.

Manufacturer Narrative

Review of the dhr showed that the housekeeping is performed per shift with no abnormality observed.Current control there is a 3 hourly outgoing inspection and 2 hourly in-process inspection in place to check for foreign matter.Based on the ftir results, the brown fm likely to be acacia.Acacia, also known as gum arabic, is used in the pharmaceutical industry as an emulsifier, stabilizing agent, suspending agent, tablet binder, and viscosity-increasing agent.Review manufacturing process there is no process that can introduce this type of fm.Since the returned sample has been opened prior for investigation, it is no longer in the condition which product was ship out.Hence, the root cause could not be determined.

Event Description

Sealed syringe packet, however dirty syringe with brown substance evident inside.

• Brand Name: BD SYRINGE 10ML E/T
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19057027
• MDR Text Key: 340455800
• Report Number: 2243072-2024-00517
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302146
• Device Lot Number: 3292938
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/07/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1