MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SAFETYGLIDE NEEDLES; SYRINGE, ANTISTICK

Catalog Number	305950
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material#: 305950 batch#: 3289428 it was reported that the bd safetyglide needles had rust / corrosion.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached issue - three packages with rusty needles item - 305950 lot - 3289428 po#1: 23840404.
Additional Manufacturer Narrative
Investigation summary: about 400 material# 305950 syringes with needle were received with the customer's complaint of rusty needles.The investigated samples included 4 opened trays with 7 unopened as well as 5 bags with needles inside.90 of the received needles had rust covering the entire needle surface.This verified the customer's complaint.None of the 7 unopened trays had rust on any of the needles.This is an extremely rare issue and the manufacturer's engineering team was notified.The needle is made of corrosive resistant stainless steel, but under special conditions (such as in the air containing chlorinated chemicals), the head of the needle core may rust.The manufacturing plant does not have the conditions to cause the defect in the production process.The root cause of this failure is unknown.
Event or Problem Description
Samples received.

• Brand Name: SAFETYGLIDE NEEDLES
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20403263
• Report Number: 1920898-2024-00147
• Device Sequence Number: 14297615
• Product Code: MEG
• UDI-Device Identifier: 00382903059508
• UDI-Public: (01)00382903059508
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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
• Operator of Device: Other
• Device Catalogue Number: 305950
• Device Lot Number: 3289428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown