MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT SYRINGE S2; SYRINGE/PISTON

Catalog Number 300296

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/18/2023

Event Type  malfunction  

Event Description

It was reported that bd discardit syringe s2 leaked at luer connection while drawing fluid.The following information was provided by the initial reporter, translated from french to english: when sampling with the syringe, air can infiltrate, causing water to escape through the head.There was no impact on the patient but a delay in the preparation of care the syringe is not contaminated with blood but was used to collect a nacl solution.

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.

• Brand Name: BD DISCARDIT SYRINGE S2
• 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: 18510457
• MDR Text Key: 333332128
• Report Number: 3002682307-2023-00371
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903002962
• UDI-Public: (01)00382903002962
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• 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: 2310184
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1