MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB; SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE

Catalog Number	303191
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
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
It was reported that syringe 10ml saline posiflush safescrub contained foreign matter.Verbatim: the customer has found black matter in one of the syringes.2 flushes were found with particles inside the flush.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported black matter was found in one of the syringes.To support the investigation, our quality team received two empty syringes without flow wrap packaging or tip caps for evaluation.A visual inspection was performed, and no defects, imperfections, or foreign matter were observed.A device history record review was completed for material number 303191, lot 5162275.The review identified no quality issues during production that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections complied with specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation, including analysis of the returned samples, the customers reported condition could not be confirmed.
Event or Problem Description
No adverse events or patient injury.

• Brand Name: BD SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB
• Common Device Name: SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 23950393
• Report Number: 1911916-2025-00826
• Device Sequence Number: 10724946
• Product Code: QTI
• UDI-Device Identifier: 00382903031917
• UDI-Public: (01)00382903031917(17)280531(10)5162275
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/09/2026

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: 5162275
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown