MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML REG PR SALINE 10ML FILL; INTRAVASCULAR CATHETER

Model Number 306546

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that a nurse noticed a foreign particle on the inside of a flush syringe.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows the syringe barrel label and the other photo shows the syringe with a foreign matter inside.A device history record review was completed for provided material number 306546, lot number 0293982.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without a physical sample analysis a probable root cause could not be offered.

Event Description

It was reported that a syringe 10ml reg pr saline 10ml fill was found to have foreign matter during use.The following was reported by the initial reporter: "per complaint details received: a nurse noticed a foreign particle on the inside of a flush syringe just as they were about to administer it to the patient.I have included pics in my email.This the 2nd occurrence for this customer (different location but same acct) in the last 2 weeks.".

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11953610
• MDR Text Key: 261074621
• Report Number: 1911916-2021-00528
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065463
• UDI-Public: 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: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2021

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 Expiration Date: 10/31/2023
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 0293982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1