MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD ORAL SYRINGE; SYRINGE ORAL 3ML AMBER

Catalog Number 305210

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

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that the bd oral syringe had foreign matter.The following information was provided by the initial reporter: "i'd like raise a complaint regarding particles found in two syringe barrels on the plungers reported by our client in japan.Their analysis reported the particles as polyethylene in one syringe and polyurethane in the when analyzed by ftir, and elemental analysis showed high levels of silicon.Could you please investigate and report within 30 days." bd catalog no 305210.Lot 2343071 & 2333095 (both lots used for packing the product lot in question).

Manufacturer Narrative

B.3.The date received by manufacturer has been used for this field.D.4.Other lot number includes 2343071.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.H.4.Other lot number device manufacture date is 2022-12-09.

• Brand Name: BD ORAL SYRINGE
• Type of Device: SYRINGE ORAL 3ML AMBER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18890766
• MDR Text Key: 337581877
• Report Number: 1213809-2024-00162
• Device Sequence Number: 1
• Product Code: KYW
• UDI-Device Identifier: 50382903052108
• UDI-Public: (01)50382903052108
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• 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
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305210
• Device Lot Number: 2333095
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1