MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML REG PR SALINE 10ML FILL; 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 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Device problem code: a180104 - device contamination with chemical or other material patient problem code: f27 ¿ no patient involvement.

Event Description

Material #: 306546 batch#: unknown it was reported by customer that recently had 2 more syringes that look exactly the same way.Do i need to quarantine the whole box? did you all ever send out a recall? i am starting to get uncomfortable with these flushes.

Event Description

Additional information received.I uploaded two sets of pictures prior.No patient was reached by these.They were discovered when pharmacy was loading them out on the units.The ndc is 08290-3065-46 lot 3142760.We sent back the first few and have 2 more boxes waiting for your prepaid shipping label.It appears that there is a dried red substance on the hub of the luer lock syringe.To date, we have discovered 3 total syringes this way.We did separate all syringes with that lot and are just waiting on you all for a shipping label.Once again, no patient impact.Material #: 306546, batch#: unknown.It was reported by customer that recently had 2 more syringes that look exactly the same way.Do i need to quarantine the whole box? did you all ever send out a recall? i am starting to get uncomfortable with these flushes.Verbatim: complaint received via email(s) attached.I recently had 2 more syringes that look exactly the same way.Do i need to quarantine the whole box? did you all ever send out a recall? i am starting to get uncomfortable with these flushes.

Manufacturer Narrative

(b)(4) follow up for device evaluation.It was reported there is a dried red substance on the hub of the syringe.To aid in the investigation, fifty-nine samples in sealed packaging flow wraps were received for evaluation by our quality team.A visual inspection was performed, and no defects, imperfections or foreign matter of any kind was observed.A device history record review was completed for provided material number 306546, lot 3142760.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18236404
• MDR Text Key: 329344357
• Report Number: 1911916-2023-00868
• 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: Other,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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: Health Professional
• Device Catalogue Number: 306546
• Device Lot Number: 3142760
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1