MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT SYRINGE S2; PERIPHERAL IV CATHETER

Catalog Number 309110

Device Problem Leak/Splash (1354)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that bd discard it syringe s2 10 ml air or fluid leaks beyond the plunger.The following information was provided by the initial reporter, translated from french to english: "10 ml syringe plungers not watertight.Either air gets into the syringe when doing venous return on central line or water comes out along the plunger when injecting with resistance like with picc-line".Clinical consequences: none.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• Brand Name: BD DISCARDIT SYRINGE S2
• Type of Device: PERIPHERAL IV CATHETER
• 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: 18985290
• MDR Text Key: 338679480
• Report Number: 3002682307-2024-00062
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903091102
• UDI-Public: (01)00382903091102
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309110
• Device Lot Number: 2310183
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1