MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB; SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE

Catalog Number	303191
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	05/27/2025
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Event details: material #303191.Lot #4297081.It was reported by customer that found black/brown contaminate in/on tip of syringe after removing cap.
Additional Manufacturer Narrative
(b)(6).Follow up.A report was received indicating the presence of a brown contaminant at the tip of a syringe.As the physical sample was not returned, a comprehensive evaluation could not be conducted.To support the investigation, three photographs were provided and reviewed by the quality team.Two of the images depict an empty syringe removed from its flow wrap packaging, lacking a tip cap, with a dark-colored speck visible in the luer tip of the syringe barrel.The third image displays the syringe barrel label.No additional defects or irregularities were observed.A device history record (dhr) review was completed for material number 303191, lot 4297081.The review did not identify any quality issues during the production of this lot that could be linked to the reported condition.No related quality notifications were found.All manufacturing processes and final inspections were performed in accordance with specification requirements.To date, no similar incidents have been reported for this lot.Based on the available information and photographic evidence, the customer-reported condition is confirmed.However, in the absence of the physical sample, a definitive root cause could not be determined.

• Brand Name: SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB
• Common Device Name: SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE
• 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: 22122764
• Report Number: 1911916-2025-00389
• Device Sequence Number: 4083811
• Product Code: QTI
• UDI-Device Identifier: 50382903031912
• UDI-Public: (01)50382903031912(11)241023(17)270930(10)4297081
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213955
• 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): 06/04/2025

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: 303191
• Device Lot Number: 4297081
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown