MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number 30773319

Device Problem Complete Blockage (1094)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported that the needle of the bd emerald¿ syringe with needle was blocked during use.The following information was provided by the initial reporter, translated from (b)(6): "on (b)(6)2021, when the nurse was doing aerosolized liquid medicine for patients, the liquid medicine could not be drawn out, and the needle was blocked.Replace the defective product in time.".

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as neither a lot number nor a sample was available for this incident, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD EMERALD¿ SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13238027
• MDR Text Key: 285613357
• Report Number: 3002682307-2021-00688
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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
• Report Date: 12/29/2021

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 Catalogue Number: 30773319
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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