MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 20ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE

Model Number 302830

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/03/2021

Event Type  malfunction  

Event Description

It was reported that bd 20ml syringe luer-lok¿ tip experienced a case of a broken stopper, and a case of foreign matter in the fluid path. The following information was provided by the initial reporter: one was found with a broken stopper and one was found with loose, dark particulate.

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD 20ML SYRINGE LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13120916
• MDR Text Key: 286562888
• Report Number: 1911916-2021-01306
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 302830
• Device Catalogue Number: 302830
• Device Lot Number: 1145993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial