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

Catalog Number 364314

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to damaged barrel 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 damaged barrel.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd preset¿ arterial blood collection syringe there was failure of product to contain blood/medication and 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: "when the staff collected arterial blood samples from the patient, they found that there was blood oozing out of the tube body.The inspection found that the needle barrel of the blood collection device was broken, and the blood collection device was replaced immediately to collect samples again.Lead to secondary blood collection.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16828718
• MDR Text Key: 314285205
• Report Number: 9617032-2023-00497
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364314
• Device Lot Number: 2272046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• 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