MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	306546
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
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 bd syringe 10ml reg pr saline 10ml fill contained foreign matter.1 syringe that has a black substance on the tip of the syringe and it is also on the inside threads of the syringe.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.One syringe was reported to have a black substance on the tip and threads.To support the investigation, one sample without flow wrap packaging and three photographs were received for evaluation by the quality team.Visual inspection at 10x and 30x magnification identified a dark colored particle adhered to the upper surface of the syringe barrel luer lok.The particle measured approximately 3/32 inch and appeared consistent with a piece of filter.The three photographs corresponded to the returned sample.No additional defects or imperfections were observed.This condition could occur if a filter fragment became dislodged following a repair or equipment maintenance.A device history record review was completed for material number 306546, lot 5261624.The review did not reveal any quality issues during production that could have contributed to the reported condition, and there were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer reported condition is confirmed.

• Brand Name: BD POSIFLUSH
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: 23994339
• Report Number: 1911916-2025-00833
• Device Sequence Number: 13321983
• Product Code: FOZ
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462(17)280831(10)5261624
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003553
• 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): 01/10/2026

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: Other
• Device Catalogue Number: 306546
• Device Lot Number: 5261624
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/10/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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