MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. PosiFlush XS/SF; Saline vascular access flush

Catalog Number	306553
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 306553 and lot number 5273105.The review did not identify any possible non-conformances during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, four (4) picture samples were received for evaluation by our quality team.With the picture samples alone, we were not able to reproduce the reported issue and unable to identify an exact cause.If the physical samples become available, additional investigation findings may be possible.Through examination of the pictures, the perforations appear to be normal, although this is based on the limited visibility as the syringes have already been separated.It is possible that an incorrect method of separation caused the package damage observed.It is recommended that the blister packages are separated on a horizontal plane.At this time, further action has not been determined necessary.This is the first report received for this type of issue on material 306553 and lot 5273105.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: 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 ; +1(847)393-5694
• MDR Report Key: 50458134
• Report Number: 9616657-2026-00010
• Device Sequence Number: 9898019
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: (01)00382903065530(17)280930(10)5273105
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 5273105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown