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

Catalog Number	306546
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reports were received of flushes lacking the white tip cap.To support the investigation, one sample in the packaging flow wrap received in a plastic bag and three photographs were provided for evaluation by the quality team.The returned unit is missing the syringe barrel tip cap, and the photographs provided depict the same unit.No other defects or imperfections were observed.This condition could occur if a jam occurred during the tip cap assembly process.A device history record review was completed for material number 306546, lot 5233237.The review identified no quality issues during the production of this lot that could have contributed to the reported condition, and there were no related quality notifications.All process controls and final inspections met specification requirements.The sample will be shared with associates for awareness.To date, no other similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer reported condition is confirmed.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.
Event or Problem Description
It was reported that the bd syringe 10ml reg pr saline 10ml fill tip cap was missing.The following information was provided by the initial reporter: material # 306546 batch # 5233237.Verbatim: rcc received a complaint via email.Injuries or adverse event: no.Item: 306546.Quantity affected: 1ea.Serial/lot number: (b)(6).Po: (b)(4).Are any samples available for return? yes.Are samples potentially contaminated or biohazard? no.Reported issue: we have been receiving multiple flushes without the white cap on them customer disposition request: replacement.Additional information: date of event: 12-19-2025.Total occurrences: only received 1 each nurse stated they had found three to four without caps.

• Brand Name: BD POSIFLUSH
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• 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: 24047011
• Report Number: 1911916-2025-00838
• Device Sequence Number: 13188547
• Product Code: FOZ
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462(10)5233237
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K003553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/25/2025

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: 306546
• Device Lot Number: 5233237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown