MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306547
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.It was reported that mold appeared to be present in the 10 ml saline flushes.To support the investigation, thirty-two prefilled syringes and one photograph were received for evaluation by the quality team.Thirty samples arrived in sealed flow-wrap packaging, while two samples were received without packaging.A visual inspection was conducted.The thirty samples in sealed packaging showed no defects or imperfections.Of the two samples without packaging, one syringe barrel luer tip contained lubricant from the molding process, and the other syringe exhibited a damaged luer tip with a dark-colored stain that was not embedded.The photograph provided depicted the condition observed in one of the returned samples.No additional defects or imperfections were noted.The samples were subsequently sent to a laboratory for further analysis, which confirmed that no mold was present on the returned samples.The observed conditions could occur if a jam during the molding process caused damage and left equipment lubricant on the device.A device history record review was completed for material number: 306547, lot: 5212357.The review did not reveal any quality issues during production that could have contributed to the reported condition.No related quality notifications were identified.All processes and final inspections complied with specification requirements.Verification of the molding process confirmed proper conveyor alignment and smooth product flow, with no lubricant residues observed.The samples were shared with associates for awareness.Based on the investigation and analysis of the returned samples, the condition reported by the customer has been 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 syr 10ml pump compatible saline 10ml fil had foreign matter.The following information was provided by the initial reporter: material#: 306547, lot#: 5212357.Rcc received a complaint via email.Pir team can we start investigation on #306547 10ml flush ¿ customer contact information and report below: i need to report a product quality issue of the bd syringe pfill 10ml flush 9% nacl sterile, mfg# 306547; some nursing units that are finding what appears to be mold in their 10ml saline flushes.Lot: 5212357, exp: 06-30-2028.

• Brand Name: BD POSIFLUSH
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• 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: 23785833
• Report Number: 1911916-2025-00790
• Device Sequence Number: 10477097
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479(17)280630(10)5212357
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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: 306547
• Device Lot Number: 5212357
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown