MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 27GA 3/8IN IB 25 TRAY 1000; PISTON SYRINGE

Catalog Number	305536
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	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 305536, batch # 4033092.It was reported that the bd syringe 0.5ml 27ga 3/8in ib 25 tray 1000 had foreign matter.The following information was provided by the initial reporter: verbatim: mat# 305536, lot# 4033092 red crystalized substance on the actual plunger with in the syringe.No patient involvement.Has the sample to return.
Additional Manufacturer Narrative
Investigation summary: 1 syringe tray with 1 syringe was received with the customer's complaint of foreign matter.The syringe plunger had a red substance present that verified the complaint.The substance was scrapped from syringe plunger and had a grease like composition that was similar to that of machine lubricant.Ftir (fourier transform infrared spectroscopy) analyses was then employed to test for a possible match of this material and the top matches were that of red grease used in manufacturing plant machinery.Root cause of this failure has been traced to an operator omission leading to grease contamination of the syringe plunger before packaging.The manufacturing team has been notified of this failure.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Sample received.

• Brand Name: BD SYRINGE 0.5ML 27GA 3/8IN IB 25 TRAY 1000
• Common Device Name: PISTON SYRINGE
• 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: 20614656
• Report Number: 1920898-2024-00149
• Device Sequence Number: 12650596
• Product Code: FMF
• UDI-Device Identifier: 00382903055364
• UDI-Public: (01)00382903055364(11)240402(17)290331(10)4033092
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 02/04/2025

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: Health Professional
• Device Catalogue Number: 305536
• Device Lot Number: 4033092
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown