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 /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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 the bd syringe 10ml reg pr saline 10ml fill had foreign matter.The following information was provided by the initial reporter: material # 306546 batch # 5111174 verbatim: rcc received a complaint via email.Email(s) attached.Account name: gpoid: (b)(4).Coid: (b)(4).Contract number: (b)(4).Manufacturer: bd medical.Please review and provide a response to the product quality issue reported.Please contact the facility directly for details, sample collection and resolution.When the investigation has completed, please provide health trust with a copy of the final letter in order to close out the ticket in the health trust database.I will follow up with you for a status update in a couple of weeks.Facility contact: department: materials management phone number: email: justice product catalog number:306546 product description: syringe prefilled flush 10ml saline 10ml posiflush luer lock sterile disposable latex free origin of the issue: nursing detail: on friday evening, (b)(6) 2025, nursing staff observed visible particulates after expressing a bd posiflush 0.9 sodium chloride injection, usp 10 ml, syringe from lot 5111174 into a sink.No patient was injected - occurrence identified during prep.Number of occurrences: 1.Sample available: yes, please contact the facility mentioned above directly regarding sample return instruction including labels.Lot number: 5111174.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.Visible particulates were reportedly observed after expressing a saline flush.To support the investigation, three samples were submitted for evaluation by the quality team.Two samples arrived in sealed flow-wrap packaging, while one sample was received empty without a tip cap.A visual inspection was conducted first under 10x magnification and subsequently under 30x magnification.No defects, imperfections, or particulates of any kind were identified.A review of the device history record was completed for material number 306546, lot 5111174.The review confirmed that no quality issues were detected during the production of this lot 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 and analysis of the returned samples, the reported symptom could not be 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: 23463365
• Report Number: 1911916-2025-00716
• Device Sequence Number: 9028291
• Product Code: FOZ
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462(10)5111174
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K003553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 5111174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/12/2025
• 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