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

Catalog Number	306553
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
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.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd posiflush-xs / sf was double packaged with conflicting labeling.The following information was provided by the initial reporter: caller states they have the posiflush sterile field saline syringe, ref (b)(4).A nurse noticed the syringe was double packaged.The first package is a clear packaging wrapper that says, "do not place syringe on sterile field"; this is then packaged in a second plastipak style packaging that says "may be used on sterile field using proper aseptic technique." the nurses were questioning which is correct and do not want to use the syringe in a sterile field if it is not safe.Caller wondering if this syringe is supposed to be packaged this way because both labels contradict each other.Additional information: i don¿t have a date of the event, as i was following up for someone else.No physical sample and no adverse event to my knowledge.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 306553 and lot number 2082648.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one (1) picture sample was provided for evaluation by our quality team.The blister pack sf posiflush product (306553) can be used on a sterile field using proper aseptic technique.The clear flow wrapped sp posiflush product (306546) must not be used on a sterile field.The labelling of both the sp and the sf product was confirmed to be correct and indicates the correct use for each posiflush product.The sp product and the sf product are two different products and are manufactured on separate distinct manufacturing lines.Based on the provided feedback, we are unable to conclusively determine if the reported information pertains to confusion between the two different posiflush products, sf (306553) versus sp (306546), or if there was an issue of rehandling of the product postproduction that could have impacted this potential issue e.G.Collating multiple products for subsequent delivery to customers.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
30-december-2024: i don¿t have a date of the event, as i was following up for someone else.No physical sample and no adverse event to my knowledge.14-january-2025: this was an issue brought forth by a nurse as a general question that came to our shared inbox.I don¿t have any details other than what i have sent already.We just wanted to know which ones are ok to be used on a sterile field since the outer clear packaging seemed to differ than the inner packaging verbiage.Unfortunately, i do not have a set time to set up a call as we work different tasks.Also, do not have a specific pt info.If it helps, you may close out the case.We will reach back out if anyone else brings forth the same concern.04-february-2025: the home health nurse does not have it anymore.She stated that she disposed of them in sharps container.

• 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: 21163866
• Report Number: 9616657-2025-00001
• Device Sequence Number: 11830526
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: (01)00382903065530(11)220323(17)250228(10)2082648
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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 Expiration Date: 02/28/2025
• Device Catalogue Number: 306553
• Device Lot Number: 2082648
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown