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

Catalog Number 306546

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that bd posiflush syringe had foreign matter.The following information was provided by the initial reporter: customer noted some type of debris within the flush syringe.This was identified prior to patient use.

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 Description

No additional information.

Manufacturer Narrative

To aid in the investigation of this issue, both pictures and the affected physical sample were returned for evaluation by our quality team.The syringe was removed from the original packaging and examined, confirming the presence of foreign matter.The sample was sent for attenuated total reflectance-fourier transform infrared (atr-ftir) analysis to identify the foreign matter composition.The results determined that the foreign matter was an embedded cellulose material.A device history record review was completed for provided material number 306546 and lot number 3242978.The review did not reveal any detected non-conformances during the production process that could have contributed to this incident.Following our investigation, we cannot identify a definitive root cause; however, due to the degraded condition of the embedded foreign matter in the barrel, it most likely entered prior to the molding process.This is the first report received for this type of defect on material number 306546 and lot number 3242978, our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD POSIFLUSH SYRINGE
• Type of Device: 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: 18835622
• MDR Text Key: 336855614
• Report Number: 9616657-2024-00009
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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
• Device Operator: Other
• Device Catalogue Number: 306546
• Device Lot Number: 3242978
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1