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

Catalog Number 364314

Device Problems Fluid/Blood Leak (1250); Overfill (2404)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

It was reported when using the bd preset¿ syringe with attached needle there was blood leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.The customer stated: "after the puncture, the blood flows into the arterial blood sampling device, and after the blood fills the cavity of the arterial blood sampling organ, the blood overflows from the piston.After arterial blood collection, it must be isolated from the air, but blood overflows from the piston of the arterial blood sampling device and cannot be isolated from the air, so the patient is punctured again, causing dissatisfaction among the patients.".

Manufacturer Narrative

Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and no issues were observed relating to leakage as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode leakage.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15925689
• MDR Text Key: 307668681
• Report Number: 9617032-2022-01236
• 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,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 364314
• Device Lot Number: 2041492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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