MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364314

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 01/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 while using bd preset¿ arterial blood collection syringe, there was leakage of one tube.No patient impact reported.The following information was provided by the initial reporter: "at around 10:10 on (b)(6) 2023, the nurse took an arterial blood sample from the patient, and the blood volume was 1.6ml.During the collection process, the nurse found that when the blood sample collected 0.2ml, the syringe (with spiral lines) leaked blood.The blood seeped out quickly, about 2ml.The nurse immediately pulled out the needle and pressed the blood vessel to stop the bleeding.The nurse checked and found that the syringe had a 0.5mm long crack.Injury: serious injury.".

• Brand Name: BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17910488
• MDR Text Key: 325351359
• Report Number: 9617032-2023-01412
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 364314
• Device Lot Number: 2305392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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