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 10/17/2023

Event Type  malfunction  

Event Description

Complaint from hospital.The customer complained that : 1) for lot no.3031929, white powder like substance/scar was found on luer lock tip of the syringe.2) for lot no.2354494, the white stopper was found deformed when opened for use.And obvious dirt was found on it.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f27 ¿ no patient involvement device problem code: a180104 - device contamination with chemical or other material.

Event Description

No additional information received.Complaint from hospital.The customer complained that : 1) for lot no.3031929, white powder like substance/scar was found on luer lock tip of the syringe.2) for lot no.2354494, the white stopper was found deformed when opened for use.And obvious dirt was found on it.

Manufacturer Narrative

(b)(4) follow up for device evaluation.It was reported there is a white powder like substance found on the luer lock tip of the syringe.To aid in the investigation, one sample with no packaging flow wrap and eleven photos were provided for evaluation by our quality team.A visual inspection was performed.First, with 10x magnification, and then with a 30x microscope.No foreign matter of any kind was observed.The eleven photos provided show the sample received.A device history record review was completed for provided material number 306546, lot 3031929.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.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be determined.It was reported the white cap was found deformed when opened for use and had dirt on it.To aid in the investigation, one sample in an opened packaging blister flow wrap and eleven photos were received for evaluation by our quality team.A visual inspection was performed.The tip cap is damage and has two spots of foreign matter that is rust from the sterilization trays.The eleven photos provided show the sample received.No other defects or imperfections were observed.This defect could occur if the syringe was misplaced on the sterilization fixture.A device history record review was completed for provided material number 306546, lot 2354494.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.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is 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: 18147884
• MDR Text Key: 328266467
• Report Number: 1911916-2023-00845
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2023
• 2 Devices were Involved in the Event: 1 2

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: 2354494
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1