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

Catalog Number	306553
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
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 barcode scans with incorrect expiration date.The following information was provided by the initial reporter: this lot # has an exp date of 5/31/2026.However, when the barcode is scanned into xxx, the exp date is populated as 5/26/2031.Our xxxx informatics had reviewed this case & has confirmed with xxx that this is a barcode problem.Wrong expiration date being captured.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 306553 and lot number 3149054.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, three (3) physical samples were received for evaluation by our quality team.Through examination of the samples, we were able to confirm that the expiry date format was incorrect, reading as ddmmyy when it should read as yymmdd.This is the second report received for this issue on lot number 3149054.Following the initial investigation, the root cause was determined to be that the print recipe in the bellmark system contained the incorrect expiry date format in the data string.A corrective and preventive action plan was opened to resolve the issue.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
04-june-2024: bd question: please confirm if the device was used or not used on the patient.If used on a patient confirm no harm/serious injury occurred.Answer: the product was used in some patients with the expiration date corrected on our labeling (would have been capped at 365 days anyway).

• 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: 22072450
• Report Number: 9616657-2025-00008
• Device Sequence Number: 9374758
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: (01)00382903065530(11)230529(17)260531(10)3149054
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 05/29/2025

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: 05/31/2026
• Device Catalogue Number: 306553
• Device Lot Number: 3149054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown