MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD 1-ML TUBERCULIN SYRINGE WITH 27-G X 1/2-IN PERMANENTLY ATTACHED NEEDLE; ANTISTICK SYRINGE

Model Number	305945
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	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Investigation summary: the photos and videos were received by bd for evaluation.A quality engineer was able to review the returned photos and video of a safetyglide syringe from lot #9084805 regarding item #305945 with the reported issue that one syringe had a clear liquid and the other a black speck.This is the 1st related complaint reported with the defect/condition of foreign matter with lot #9084805 regarding item #305945.A review of the device history record was completed for batch # 9084805.All inspections and challenges were performed per the applicable operations qc specifications.There was one notification noted for scratched print.Based on the photos and videos received, the investigation concluded that embecta was able to duplicate or confirm the indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and no capa/sa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause cannot be determined at this time as it is difficult to determine the identities of these materials solely from the attached photos and videos.Based on the above, no additional investigation and no capa/sa is required at this time.
Event or Problem Description
It was reported while using bd 1-ml tuberculin syringe with 27-g x 1/2-in permanently attached needle foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: "there is a problem with a syringe.1ml syringe contained a clear liquid inside the syringe, and a black speck inside one.".

• Brand Name: BD 1-ML TUBERCULIN SYRINGE WITH 27-G X 1/2-IN PERMANENTLY ATTACHED NEEDLE
• Common Device Name: ANTISTICK 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14121330
• Report Number: 1920898-2022-00237
• Device Sequence Number: 11845977
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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 Expiration Date: 03/31/2024
• Device Model Number: 305945
• Device Catalogue Number: 305945
• Device Lot Number: 9084805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown