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	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: a device history record review was completed for provided material number 306553 and lot number 5006316.The review did not reveal any detected non-conformances during the production process that could have contributed to this incident.To aid in the investigation of this issue, five (5) picture samples and four (4) physical samples were returned for evaluation by our quality team.The physical samples were returned with the shipment for related pr (b)(6) through examination of the samples, package damage and foreign brown stains were observed.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¿ 10ml saline flush syringe.(reason for mdr): a review was completed with the technical team to determine the root cause of the package damage (tear in top web) following the investigation.The technical team determined that the root cause was most likely a crash in the manufacturing process where the flange of the barrel was pushed into the paper web causing the break.
Event or Problem Description
It was reported that bd posiflush-xs / sf a tear in the top web (investigation finding) the following information was provided by the initial reporter (is not related to the reportable event see h10 for device evaluation findings): yellowing and yellow spots on the labels of the syringes.

• 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: 22374830
• Report Number: 9616657-2025-00011
• Device Sequence Number: 19987794
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: (01)00382903065530(11)250106(17)271231(10)5006316
• 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
• Report Date (Section B): 07/01/2025

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: 5006316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown