MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1-1/2 RB NS; SYRINGE, PISTON

Catalog Number 303005

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 04/02/2024

Event Type  malfunction  

Event Description

Material# 303005.Batch# 3236128.It was reported by customer that the part of the sterile rubber stopper floating in inside the vial issue when drawing up with the needle.Verbatim: rcc received a complaint via email.Email(s) attached.The customer found particulate matter appeared to be part of the sterile rubber stopper floating in inside the vial issue when drawing up with the needle.They perceived this as the problem was identified where a small piece of the rubber stopper was seen floating inside the vial after puncturing for the draw.The nursing staff began investigating the potential cause and then began collecting packing list for each occurrence they were finding.

Manufacturer Narrative

Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• Brand Name: NEEDLE 18X1-1/2 RB NS
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19115737
• MDR Text Key: 341050945
• Report Number: 1911916-2024-00261
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 50382903030052
• UDI-Public: (01)50382903030052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 303005
• Device Lot Number: 3236128
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1