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

Catalog Number	306553
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd posiflush-xs / sf packaging shreds when separated.The following information was provided by the initial reporter: when they¿re tearing lawson (b)(6) (syringe saline 10ml flush) apart several particles shed from the packaging.I did it over some black fabric so you could see how many flakes off.A little concerning in a sterile environment.
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.E1.Address information was not provided, therefore, xx was used as a place holder.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number (b)(4) and lot number 4207650.The review did not reveal any possible non-conformances which could have contributed to the reported incident.To aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality team.Through examination of the picture, particles were observed.It was determined that the particles most likely resulted from fiber tear.A small amount of fiber tear naturally occurs when separating individual blister packages and also when separating the paper top web from the plastic bottom web.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.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: posiflush -xs/sf.Device failure: package difficult to open.
Event or Problem Description
No additional information.

• 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: 21267411
• Report Number: 9616657-2025-00004
• Device Sequence Number: 3642562
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: (01)00382903065530
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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: Other
• Device Catalogue Number: 306553
• Device Lot Number: 4207650
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/18/2025; Not provided
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/27/2025; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown