MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL POSIFLUSH; PERIPHERAL IV CATHETERS

Catalog Number	306546
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	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 web.Pir attached.We observed visible particulates after expressing a bd posiflush 0.9% sodium chloride injection, usp, 10 ml syringe from lot 5111174 into a sink.Facility product details: lot: 5111174 | exp: 2028-03-31.Ref: (b)(4).Quantity on hand: approximately 14 cases (all quarantined).First observed: 2025-10-08, afternoon.No patient was injected; occurrence identified during prep.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.This complaint was found to be a duplicate after the mdr was submitted, please refer to mdr 13312419.
Event or Problem Description
(b)(4) is a duplicate complaint and will be cancelled.

• Brand Name: POSIFLUSH
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: 23459867
• Report Number: 1911916-2025-00715
• Device Sequence Number: 13032947
• Product Code: FOZ
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462(10)5111174
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/07/2025

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?: No
• 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: Not provided
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown