MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML LL; SYRINGE, PISTON

Catalog Number 300865

Device Problem Contamination (1120)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(6): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

Event Description

Product concerned: 50cc luer lock syringe, product reference: 300865, lot/expiry date: 2205042/30.04.2027.Event: black luer lock male mouthpiece.The syringe was in the isolator of the cytotoxic preparation unit.When the preparer wanted to use it, he realized the unusual color of the mouthpiece.See attached photo.

Manufacturer Narrative

One sample and photo received for investigation.Through visual inspection, it can be observed the tip of the syringe is stained with black foreign matter.The foreign matter is only found in the tip of the syringe.The tip is damaged and burnt.A device history review was performed for reported lot 2205042 , no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.This defect can occur due to burnt material generating during the molding process due to a failure between temperature controller and mold.Machines undergo routine cleaning and maintenance and injection machines are ran prior to use to remove any excess materials, rejecting the first few pieces.

Event Description

No additional info.

• Brand Name: SYRINGE 50ML LL
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18569683
• MDR Text Key: 333551640
• Report Number: 3003152976-2024-00040
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903008650
• UDI-Public: (01)00382903008650
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300865
• Device Lot Number: 2205042
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1