MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH XS/SF; SALINE VASCULAR ACCESS FLUSH

Catalog Number	306553
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd posiflush-xs / sf foreign matter in the package seal.The following information was provided by the initial reporter: while being utilized in production, it was noted that 7 eaches of item 306553, lot 5023049 had debris visible in the syringe and syringe seal.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
To aid in the investigation of this issue, five (5) picture samples and four (4) physical samples were received for evaluation by our quality team.Through examination of the samples, brown staining was observed on the blister packaging.A device history record review was completed for provided material number 306553 and lot number 5023049.The review revealed two (2) non-conformances during the production process for foreign matter.The foreign matter was related to brown staining on the xs packaging from the sterilizer.Product was held, sampled, and released based on passing the sampling procedures.The brownish spots on the packaging can occur during the steam sterilization process.This is a cosmetic defect only and the integrity of the product and the sterile barriers is not affected.Furthermore, microbial permeability testing, cytotoxicity testing, and testing for residual solvents and volatile species has been completed on packages displaying the brownish stain.The testing confirmed that they do not present any risk to the use of the product and have no impact on the effectiveness, sterility, quality or safety of bd posiflush¿ 10 ml saline flush syringe.

• Brand Name: BD POSIFLUSH XS/SF
• Common Device Name: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22494932
• Report Number: 9616657-2025-00013
• Device Sequence Number: 11820903
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: (01)00382903065530(10)5023049
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153481
• 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,Followup
• Report Date (Section B): 09/09/2025

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: 306553
• Device Lot Number: 5023049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown