MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT SYRINGE; SYRINGE, PISTON

Catalog Number 300296

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.

Event Description

It was reported that bd discardit syringe leaked past the plunger.The following information was provided by the initial reporter: when administering the induction drug (propofol), in a 20ml syringe, the drug started to discharge outside the syringe from the base of the plunger.When did the incident occur? during use customer do not have the syringe left.31 oct ¿no, there has not been any patient impact.This was only one outdated product.¿.

• Brand Name: BD DISCARDIT SYRINGE
• Type of Device: SYRINGE, PISTON
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18193106
• MDR Text Key: 329904852
• Report Number: 3002682307-2023-00333
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903002962
• UDI-Public: (01)00382903002962
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2023

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: 300296
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1